A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Coformation of Vibostolimab (MK-7684) with Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants with Selected Solid Tumors

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

Primary Objectives:

Objective: To compare MK-7684A to pembrolizumab alone with respect to ORR per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
Hypothesis (H1): MK-7684A is superior to pembrolizumab alone with respect to ORR per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
Objective: To compare MK-7684A to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
Hypothesis (H2): MK-7684A is superior to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
Objective: To evaluate MK-7684A alone or in combination with other anticancer therapies with respect to ORR per RECIST 1.1 as assessed by the investigator in participants with selected solid tumors, excluding those with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.

Secondary Objectives:

Objective: To evaluate MK-7684A alone or in combination with other anticancer therapies with respect to OS in participants with selected solid tumors
Objective: To evaluate MK-7684A alone or in combination with other anticancer therapies with respect to PFS per RECIST 1.1 as assessed by the investigator in participants with selected solid tumors, excluding those with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1
Objective: To evaluate MK-7684A alone with respect to DOR per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1.
Objective: To evaluate MK-7684A alone or in combination with other anticancer therapies with respect to DOR per RECIST 1.1 as assessed by the investigator in participants with selected solid tumors, excluding those with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1
Objective: To evaluate change from baseline in HRQoL using the EORTC QLQ-C30 in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1
To evaluate the safety and tolerability of MK-7684A alone or in combination with other anticancer therapies

Eligibility

Inclusion Criteria:

One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors:

Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Endometrial cancer
Head and neck squamous cell carcinoma (HNSCC)
Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)
Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
Triple-negative breast cancer (TNBC)
Hepatocellular carcinoma (HCC)
Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
Ovarian cancer
Gastric cancer

Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
Adequately controlled blood pressure (BP) with or without antihypertensive medications.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
Male participants must agree to follow contraceptive guidance.
Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
Adequate organ function.

Exclusion Criteria:

History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.
Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
Active autoimmune disease that has required systemic treatment in past 2 years.
Active infection requiring systemic therapy.
Concurrent active hepatitis B and hepatitis C virus infection.
History of allogenic tissue/solid organ transplant.
Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices