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7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors
EU CTIS ID: 2023-505284-36-00
What this study is testing
1. To compare MK-7684A to pembrolizumab (MK-3475) 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. 2. To compare MK-7684A to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed BICR in participants with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1. 3. 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 1) those with cervical cancer whose tumors express PD-L1 (CPS ≥1) enrolled in Cohort A1, 2) those enrolled in Cohort I. 4. To evaluate MK-7684A in combination with other anticancer therapies with respect to PFS per RECIST 1.1 at 9 months (PFS-9) and 12 months (PFS-12) as assessed by the investigator in participants with previously untreated BRCA1/2 nonmutated and HRD-negative advanced epithelial ovarian cancer enrolled in Cohort I.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- 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
- 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
See the full eligibility 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
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- Colombia
- Chile
- Japan
- Israel
- Korea, Republic of
- Taiwan
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; Colombia; Chile; Japan; Israel and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.