Healthcare Professionals

INVESTIGATORS NETWORK

Our team is comprised of physicians with extensive experience in clinical research who work to ensure the best care for their patients.

GASTROINTESTINAL ONCOLOGY & HEREDITARY CANCER

Marcia Cruz Correa, MD, PhD, AGAF, FASGE

HEMATOLOGY-ONCOLOGY

Elías Sobrino Najul, MD
José Ortega, MD
José Sobrino Catoni, MD
Karina Arocho González, MD
María V. García Pallas, MD
Noridza Rivera Rodríguez, MD
Luis Delgado, MD
Omayra González, MD
Pedro F. Escobar Rodríguez, MD
Santa E. Merle Ramírez, MD

UROLOGY

Eduardo Canto, MD
Antonio Puras, MD
Ricardo Sánchez-Ortiz, MD

GASTROENTEROLOGY

Kermit Richiez, MD
José Rivera Acosta, MD
Suzette Rivera MacMurray, MD
Artemio Santiago, MD

RADIATION ONCOLOGY

Roberto Santiago, MD

DERMATOLOGY

Hiram Ruiz, MD

AFFILIATED TEAM:

Adelaida Ortiz, MD
Ana Cecilia Salas, PsyD, MSc
Edgar Colón Negrón, MD
Angel Muntaner Morales, MD

ENROLLING STUDIES

COLORECTAL CANCER
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator’s Choice Chemotherapy for the Treatment of Patients With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW) NCT04008030
STUDY DESCRIPTION
This is a Phase 3b Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or an Investigator’s Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer.
INCLUSION CRITERIA:

Histologically confirmed recurrent or metastatic colorectal cancer (CRC)
Known tumor MSI-H or dMMR status per local standard of practice
Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1
Measurable disease by CT or MRI per RECIST 1.1 criteria

COLORECTAL CANCER
BESPOKE study of ctDNA guided therapy in colorectal cancer (CRC) Signatera detects and tracks circulating tumor DNA (ctDNA) using a personalized, tumor-informed assay NCT04264702
STUDY DESCRIPTION
This is a first prospective, multi-center clinical study examining the role of ctDNA in: MRD Assessment | Adjuvant Treatment Guidance | Recurrence Monitoring. BESPOKE CRC will measure changes in treatment decisions and clinical outcomes based on the use of Signatera in patients with stage II and III colorectal cancer. The study will enroll at least 1,000 patients. Natera and its collaborators will collect clinical utility and outcomes data on enrolled patients for two years.
INCLUSION CRITERIA:

Pathologic Stage II and III
Has residual surgically resected FFPE tissue from adenocarcinoma of the colon or rectum
ECOG performance status ≤ 2
Clinically eligible for chemotherapy
Able to tolerate collection of up to 30 mL of blood via venipuncture
18 years or older
Able to provide written informed consent

METASTATIC COLORECTAL CANCER
Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer (SOLARIS) NCT04094688
STUDY DESCRIPTION
This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth.
INCLUSION CRITERIA:

Histologically confirmed advanced/ metastatic colorectal adenocarcinoma
No mismatch repair deficiency (dMMR) or high-frequency microsatellite instability (MSI-H) disease
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version
No prior systemic treatment for metastatic disease
No continuous daily use of vitamin D supplements

GASTRIC OR GASTROESOPHAGEAL JUNCTION CARCINOMA
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma NCT04318080
STUDY DESCRIPTION
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
INCLUSION CRITERIA:

Locally advanced unresectable or GC or GEJ carcinoma
No previous systemic therapy
At least 1 measurable lesion as defined per RECIST v1.1

INTERMEDIATE STAGE HEPATOCELLULAR CARCINOMA
Nivolumab and Ipilimumab or Nivolumab or Placebo Plus TACE in Intermediate-stage Liver Cancer Biliary (Cholangiocarcinoma) NCT04340193
STUDY DESCRIPTION
This is a randomized, Multi-center, Double-blinded, Placebo-controlled phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or placebo in Combination with Trans-arterial Chemo Embolization (TACE) in patients with Intermediate-stage Hepatocellular Carcinoma (HCC).
INCLUSION CRITERIA:

Intermediate-stage HCC
No prior TACE
Tumor exceeds BMU7 criteria
Child-Pugh score 5-6
ECOG PS 0-1
No EHS, NO, VPO, VvO

BILE DUCT CANCER (CHOLANGIOCARCINOMA)
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma NCT03773302
STUDY DESCRIPTION
This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor receptor (FGFR) genetic alterations.
INCLUSION CRITERIA:

Adult patients with histologically or cytologically confirmed holangiocarcinoma at the time of diagnosis
Patients with cancers of the gallbladder or ampulla of Vater are not eligible
Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease

HEPATOCELLULAR UNRESECTABLE CARCINOMA
Study of BGB-A317 in Participants With Previously Treated Unresectable HCC NCT04318080
STUDY DESCRIPTION
This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Participants with Previously Treated Hepatocellular Unresectable Carcinoma.
INCLUSION CRITERIA:

Histologically confirmed HCC
Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
Has received at least 1 line of systemic therapy for unresectable HCC
Has at least 1 measurable lesion as defined per RECIST v1.1
Child-Pugh score A
Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Adequate organ function

METASTATIC / ADVANCED SOLID TUMORS
Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007) NCT03821935
STUDY DESCRIPTION
This is a Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer.
INCLUSION CRITERIA:

Advanced (metastatic and/or unresectable) SOLID TUMORS
Previously treated Homologous Recombinant Repair mutation tumors (HRR)
Tumor with deleterious mutations in any of the 15 HRR genes
Failed to standard of care therapies

METASTATIC / ADVANCED SOLID TUMORS
Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Participants With Locally Advanced or Metastatic Solid Tumors NCT03821935
STUDY DESCRIPTION
The study will determine the recommended Phase 2 dose (RP2D) of ABBV-151 administered as monotherapy and in combination with ABBV-181 as well as to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-151 alone and in combination with ABBV-181.
INCLUSION CRITERIA:

Participants with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition
TNBC – Female or male participants with confirmed breast adenocarcinoma that is ERnegative, PR-negative, and HER2-negative
Urothelial cancer of the bladder and urinary tract and must have progressed following treatment with a platinum-based regimen
HCC and must have disease progression during or after 1 prior line of systemic therapy
HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen

HEAD & NECK SQUAMOUS CELL CARCINOMA (HNSCC)
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors NCT03071757
STUDY DESCRIPTION
This is a Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors The study will consist of: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (head and neck cancer cohort) and 18F-AraG Imaging Substudy.
INCLUSION CRITERIA:

Histologic or cytology diagnosis of a known immunogenic solid tumor
Recurrent HNSCC that are not candidates for curative treatment with local or systemic therapy, or metastatic HNSCC who previously received platinum-based therapy and progressed either during or after one anti-PD-1/PL-L1-based therapy
Recurrent HNSCC that are not candidates for curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC considered incurable by local therapies with disease progression on or after platinum-containing chemotherapy. Subjects must be treatment-naïve to a PD-1/PD-L1 targeting agent. Subjects must have refused available standard-of -care anti-PD-1 or PD-L1 therapies.

MUSCLE INVASIVE BLADDER CANCER CHEMORADIOTHERAPY +/- PEMBROLIZUMAB
A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992) NCT04241185
STUDY DESCRIPTION
This is a Phase 3, randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive bladder Cancer (MIBC) (KEYNOTE-992).
INCLUSION CRITERIA:

Male and female participants at least 18 years of age with MIBC clinical stage T2-T4aN0M0 who elect to receive CRT

METASTATIC CR PROSTATE CANCER
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer Urothelial NCT04100018
STUDY DESCRIPTION
The purpose of this study is to test the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second generation hormonal manipulation.
INCLUSION CRITERIA:

Histologic confirmation of adenocarcinoma of the prostate without small cell features
Current evidence of metastatic disease
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Documented prostate cancer progression criteria within 6 months prior to screening
Chemotherapy-naïve for metastatic castration- resistant prostate cancer (mCRPC),
Sufficient tumor samples from either a fresh biopsy (obtained during screening) or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides

UROTHELIAL CARCINOMA
Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations NCT04197986
STUDY DESCRIPTION
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral targeted FGFR1-3 inhibitor, infigratinib, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements) who have disease that is considered at high risk for recurrence with surgery alone.
INCLUSION CRITERIA:

Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations
If the patient received neoadjuvant chemotherapy, pathologic stage at surgical resection must be AJCC Stage ≥ ypT2 and/or yN+
If the patient did not receive neoadjuvant chemotherapy:- Must be ineligible to receive cisplatin-based adjuvant chemotherapy per the Galsky criteria- Pathologic stage must be AJCC Stage ≥pT2 pN0-2 M0 (post-lymphadenectomy or no lymphadenectomy [pNx]) for upper tract disease- Pathologic stage should be AJCC Stage ≥pT3 or pN+ (bladder cancer)
Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Patients must have no evidence of metastatic disease

ADVANCED KIDNEY CANCER
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study NCT04094688
STUDY DESCRIPTION
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
INCLUSION CRITERIA:

Histologic confirmation of adenocarcinoma of the prostate without small
Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan- Histologically confirmed diagnosis of metastatic: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe renal cell carcinoma (RCC)- Hematoxylin and eosin (H&E) slides from diagnostic tumor tissue for retrospective central pathology review
Patients may have received any number of prior anti-cancer treatments or be treatment naive (with the exception of patients with small cell carcinoma of the bladder, whom should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment)

ADVANCED KIDNEY CANCER
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study NCT03793166
STUDY DESCRIPTION
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better.
INCLUSION CRITERIA:

STEP I REGISTRATION CRITERIA
Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features
Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1.
Measurable disease as defined in the protocol
Intermediate or poor risk patients per International Metastatic Renal Cell Carcinoma Database (IMDC)
Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment
Karnofsky performance status >= 70%.
No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents
No prior previous systemic therapy for renal cell carcinoma
No cancer therapy less than 28 days prior to registration
Not pregnant and not nursing
Absolute neutrophil count (ANC) >= 1,500/mm^3

ACUTE MYELOID LEUKEMIA
A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival (VIALE-M) NCT04102020
STUDY DESCRIPTION
The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy.
INCLUSION CRITERIA:

Diagnosis of newly diagnosed acute myeloid leukemia (AML)
Participant meets the following disease activity criteria:- Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of planned induction and consolidation chemotherapy- Achieved first CR + CRi within 4 months of enrollment or be no more than 75 days since last dose of conventional therapy- AML has intermediate or adverse risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol

MYELODYSPLASTIC SYNDROMES (MDS)
A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS) NCT04401748
STUDY DESCRIPTION
This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.
INCLUSION CRITERIA:

Participant must have documented diagnosis of untreated de novo MDS with:- International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of > 3) and- Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2

CLASSICAL HODGKIN LYMPHOMA
A Study of BGB-A317 as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma NCT04318080
STUDY DESCRIPTION
The study is to evaluate the efficacy of BGB-A317 assessed by Independent Review Committee (IRC) in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification.
INCLUSION CRITERIA:

≥ 18 years of age at time of informed consent
Histologically confirmed relapsed or refractory cHL (biopsy from diagnosis or at any relapse is acceptable)
Participants must have measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in the longest diameter, or ≥ 1 extra-nodal lesion (e.g. hepatic nodules) that is > 1 cm in the longest diameter
Life expectancy ≥ 12 weeks

LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors NCT03821935
STUDY DESCRIPTION
A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose- escalation phase and a dose-expansion phase.
INCLUSION CRITERIA:

Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

ADVANCED NON-SMALL CELL LUNG CANCER
A Study of Lazertinib as Monotherapy or in Combination With JNJ-61186372 in Participants With Advanced Non-small Cell Lung Cancer NCT03649971
STUDY DESCRIPTION
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of lazertinib when combined with JNJ-61186372 (Phase 1b), to characterize the safety and tolerability of lazertinib and JNJ 61186372 combinations at the RP2CD in participants with advanced NSCLC with documented EGFR mutation (Phase 1b expansion cohorts) and to estimate the antitumor activity of lazertinib and JNJ 61186372 combinations at the RP2CD in participants with advanced NSCLC with documented EGFR mutation (Phase 1b expansion cohorts).
INCLUSION CRITERIA:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with previously epidermal growth factor receptor (EGFR) mutation (identified locally in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory [or equivalent]) that is metastatic or unresectable, and have progressed after standard of care front-line therapy, and exhausted available options with targeted therapy.
Evaluable disease
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Participants must meet the study protocol defined laboratory criteria without having a history of red blood cell transfusion, platelet transfusion, or granulocyte-colony stimulating factor support within 7 days prior to the date of the test
A woman of childbearing potential: Must have a negative serum beta human chorionic gonadotropin at screening; Must agree not to breast-feed during the study and for 6 months after the last dose of study intervention. Must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study intervention

LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA) NCT04487080
STUDY DESCRIPTION
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
INCLUSION CRITERIA:

Participant must have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) not amenable to curative therapy
Participant must have a tumor that was previously determined to have exon 19 deletions (Exon 19del) or Exon 21 L858R substitution
Unstained tumor tissue (in a quantity sufficient to allow for central analysis of epidermal growth factor receptor (EGFR) mutation status, see Laboratory Manual) and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis), both collected at or after the diagnosis of locally advanced or metastatic NSCLC, must be provided
Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level
Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy

METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)
Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008) NCT03906071
STUDY DESCRIPTION
This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).
INCLUSION CRITERIA:

Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c)
Has PD on treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb)
Has PD during/after platinum doublet chemotherapy for metastatic disease
Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy
Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor
Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI)
Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy [antiPD-1/PDL1], from the primary lesion or a metastatic lesion)
Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy [anti-PD-1/PD-L1] and before receiving a randomization number), of a tumor lesion not previously irradiated

CROHN’S DISEASE
A Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (VIVID-1) NCT03926130
STUDY DESCRIPTION
This is a Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn’s Disease.
INCLUSION CRITERIA:

Diagnosis of CD or fistulizing CD for ≥ 3 months confirmed by clinical, endoscopic and histological criteria
Participants with a family history of CRC, personal history of increased CRC risk, age >50 years, or other known risk factor
Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD

CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)
Cemiplimab Survivorship Epidemiology (CASE) NCT03836105
STUDY DESCRIPTION
This is a Cemiplimab Survivorship Epidemiology (CASE) Study.
INCLUSION CRITERIA:

Patients receiving treatment with cemiplimab for CSCC, or initiating treatment with cemiplimab for CSCC

Histologically confirmed recurrent or metastatic colorectal cancer (CRC)
Known tumor MSI-H or dMMR status per local standard of practice
Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1
Measurable disease by CT or MRI per RECIST 1.1 criteria

Pathologic Stage II and III
Has residual surgically resected FFPE tissue from adenocarcinoma of the colon or rectum
ECOG performance status ≤ 2
Clinically eligible for chemotherapy
Able to tolerate collection of up to 30 mL of blood via venipuncture
18 years or older
Able to provide written informed consent

Histologically confirmed advanced/ metastatic colorectal adenocarcinoma
No mismatch repair deficiency (dMMR) or high-frequency microsatellite instability (MSI-H) disease
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version
No prior systemic treatment for metastatic disease
No continuous daily use of vitamin D supplements

Locally advanced unresectable or GC or GEJ carcinoma
No previous systemic therapy
At least 1 measurable lesion as defined per RECIST v1.1

Intermediate-stage HCC
No prior TACE
Tumor exceeds BMU7 criteria
Child-Pugh score 5-6
ECOG PS 0-1
No EHS, NO, VPO, VvO

Adult patients with histologically or cytologically confirmed holangiocarcinoma at the time of diagnosis
Patients with cancers of the gallbladder or ampulla of Vater are not eligible
Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease

Histologically confirmed HCC
Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
Has received at least 1 line of systemic therapy for unresectable HCC
Has at least 1 measurable lesion as defined per RECIST v1.1
Child-Pugh score A
Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Adequate organ function

Advanced (metastatic and/or unresectable) SOLID TUMORS
Previously treated Homologous Recombinant Repair mutation tumors (HRR)
Tumor with deleterious mutations in any of the 15 HRR genes
Failed to standard of care therapies

Participants with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition
TNBC – Female or male participants with confirmed breast adenocarcinoma that is ERnegative, PR-negative, and HER2-negative
Urothelial cancer of the bladder and urinary tract and must have progressed following treatment with a platinum-based regimen
HCC and must have disease progression during or after 1 prior line of systemic therapy
HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen

Histologic or cytology diagnosis of a known immunogenic solid tumor
Recurrent HNSCC that are not candidates for curative treatment with local or systemic therapy, or metastatic HNSCC who previously received platinum-based therapy and progressed either during or after one anti-PD-1/PL-L1-based therapy
Recurrent HNSCC that are not candidates for curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC considered incurable by local therapies with disease progression on or after platinum-containing chemotherapy. Subjects must be treatment-naïve to a PD-1/PD-L1 targeting agent. Subjects must have refused available standard-of -care anti-PD-1 or PD-L1 therapies.

Male and female participants at least 18 years of age with MIBC clinical stage T2-T4aN0M0 who elect to receive CRT

Histologic confirmation of adenocarcinoma of the prostate without small cell features
Current evidence of metastatic disease
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Documented prostate cancer progression criteria within 6 months prior to screening
Chemotherapy-naïve for metastatic castration- resistant prostate cancer (mCRPC),
Sufficient tumor samples from either a fresh biopsy (obtained during screening) or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides

Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations
If the patient received neoadjuvant chemotherapy, pathologic stage at surgical resection must be AJCC Stage ≥ ypT2 and/or yN+
If the patient did not receive neoadjuvant chemotherapy:- Must be ineligible to receive cisplatin-based adjuvant chemotherapy per the Galsky criteria- Pathologic stage must be AJCC Stage ≥pT2 pN0-2 M0 (post-lymphadenectomy or no lymphadenectomy [pNx]) for upper tract disease- Pathologic stage should be AJCC Stage ≥pT3 or pN+ (bladder cancer)
Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Patients must have no evidence of metastatic disease

Histologic confirmation of adenocarcinoma of the prostate without small
Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan- Histologically confirmed diagnosis of metastatic: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe renal cell carcinoma (RCC)- Hematoxylin and eosin (H&E) slides from diagnostic tumor tissue for retrospective central pathology review
Patients may have received any number of prior anti-cancer treatments or be treatment naive (with the exception of patients with small cell carcinoma of the bladder, whom should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment)

ADVANCED KIDNEY CANCER
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study NCT03793166
STUDY DESCRIPTION
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better.
INCLUSION CRITERIA:

STEP I REGISTRATION CRITERIA
Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features
Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1.
Measurable disease as defined in the protocol
Intermediate or poor risk patients per International Metastatic Renal Cell Carcinoma Database (IMDC)
Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment
Karnofsky performance status >= 70%.
No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents
No prior previous systemic therapy for renal cell carcinoma
No cancer therapy less than 28 days prior to registration
Not pregnant and not nursing
Absolute neutrophil count (ANC) >= 1,500/mm^3

Diagnosis of newly diagnosed acute myeloid leukemia (AML)
Participant meets the following disease activity criteria:- Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of planned induction and consolidation chemotherapy- Achieved first CR + CRi within 4 months of enrollment or be no more than 75 days since last dose of conventional therapy- AML has intermediate or adverse risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol

Participant must have documented diagnosis of untreated de novo MDS with:- International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of > 3) and- Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2

≥ 18 years of age at time of informed consent
Histologically confirmed relapsed or refractory cHL (biopsy from diagnosis or at any relapse is acceptable)
Participants must have measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in the longest diameter, or ≥ 1 extra-nodal lesion (e.g. hepatic nodules) that is > 1 cm in the longest diameter
Life expectancy ≥ 12 weeks

Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with previously epidermal growth factor receptor (EGFR) mutation (identified locally in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory [or equivalent]) that is metastatic or unresectable, and have progressed after standard of care front-line therapy, and exhausted available options with targeted therapy.
Evaluable disease
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Participants must meet the study protocol defined laboratory criteria without having a history of red blood cell transfusion, platelet transfusion, or granulocyte-colony stimulating factor support within 7 days prior to the date of the test
A woman of childbearing potential: Must have a negative serum beta human chorionic gonadotropin at screening; Must agree not to breast-feed during the study and for 6 months after the last dose of study intervention. Must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study intervention

Participant must have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) not amenable to curative therapy
Participant must have a tumor that was previously determined to have exon 19 deletions (Exon 19del) or Exon 21 L858R substitution
Unstained tumor tissue (in a quantity sufficient to allow for central analysis of epidermal growth factor receptor (EGFR) mutation status, see Laboratory Manual) and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis), both collected at or after the diagnosis of locally advanced or metastatic NSCLC, must be provided
Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level
Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy

Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c)
Has PD on treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb)
Has PD during/after platinum doublet chemotherapy for metastatic disease
Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy
Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor
Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI)
Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy [antiPD-1/PDL1], from the primary lesion or a metastatic lesion)
Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy [anti-PD-1/PD-L1] and before receiving a randomization number), of a tumor lesion not previously irradiated

Diagnosis of CD or fistulizing CD for ≥ 3 months confirmed by clinical, endoscopic and histological criteria
Participants with a family history of CRC, personal history of increased CRC risk, age >50 years, or other known risk factor
Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD

CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)
Cemiplimab Survivorship Epidemiology (CASE) NCT03836105
STUDY DESCRIPTION
This is a Cemiplimab Survivorship Epidemiology (CASE) Study.
INCLUSION CRITERIA:

Patients receiving treatment with cemiplimab for CSCC, or initiating treatment with cemiplimab for CSCC

GENETIC TESTING

With the promise of precision medicine becoming a reality, genetic testing has become the standard of care for many cancer types– and required for certain therapies. More than ever, oncologists need a trusted profiling partner to provide reliable, high quality molecular information to guide precise and individualized treatment decisions.
PROACTIVE GENETIC TESTING
Proactive genetic testing for healthy and individuals with personal or family history of cancer. Genetic tests for healthy adults who want to understand their DNA and focus on cancer prevention.

Genetic testing for individuals with cancer might provide information to understand the cause for the development of cancer.
Testing for known familial genetic mutations provides information about cancer risk, as well as potential therapeutic options.
Proactive genetic testing offers healthy adults without a strong personal or family history of cancer an opportunity to learn about how their genes could potentially impact their health.

Proactive genetic testing offers testing options that analyze genes that are well-established indicators of a significantly increased risk of developing hereditary cancers, cardiovascular conditions, and other medically important disorders.
Our diagnostic-grade tests are performed in a CLIA- and CAP-certified laboratory and reviewed by our team of Ph.D. scientists, lab directors, and board-certified oncologists.

COMPREHENSIVE TUMOR PROFILING
This technology approach allows our medical teams to decode cancer and more fully understand the biology of the tumor – therefore helping oncologists’ better plan their attack.

Next-Generation Sequencing (NGS): rapidly examines and more broadly detects DNA mutations, copy number variations and gene fusions across the genome
Immunohistochemistry (IHC): determines level of protein expression
In situ Hybridization: detects gene deletions, amplifications, translocations and fusions

Sanger Sequencing: examines strands of DNA to identify mutations by analyzing long contiguous sequencing reads
Pyro Sequencing (PyroSeq): detects and quantifies mutations, methylation, etc. through sequencing by synthesis
Fragment Analysis (FA/Frag. Analysis): detects changes in DNA or RNA to indicate the presence or absence of genetic marker

MINIMAL RESIDUAL DISEASE (MDR) ASSESSMENT AND TREATMENT MONITORING
Personalized, tumor-informed assay optimized to detect circulating tumor DNA (ctDNA) for molecular residual disease (MRD) assessment and recurrence monitoring for patients previously diagnosed with cancer, with broad utility for cancer management.

Highly accurate MRD testing uniquely personalized to each patient’s tumor mutation signature
Highly sensitive non-invasive assay to detect MRD earlier than other standard of care clinical tools
Earlier cancer recurrence monitoring to help inform adjuvant treatment decisions

Custom-built for each patient, using tumor tissue from surgical resection
Highest level of monitoring accuracy when determining whether to augment or reduce therapy

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