MK-7684A for Advanced Cancers

Recruiting at82 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment that combines two medications to see if it works better than the current treatment for serious cancers, particularly cervical cancer. One of the medications has shown promising results in treating various cancers, including cervical cancer. The goal is to find out if this combination can improve patient outcomes by helping the immune system fight cancer more effectively.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with certain advanced solid tumors, including various carcinomas like cervical, endometrial, and esophageal cancer. Participants must not be pregnant or breastfeeding and should agree to use contraception. They need controlled blood pressure, adequate organ function, measurable disease per RECIST v1.1 criteria, and well-controlled HIV if applicable.

Inclusion Criteria

I have endometrial cancer.

I agree to follow the study's rules for using birth control.

My blood pressure is under control, with or without medication.

Exclusion Criteria

I have both hepatitis B and C.

I have had serious heart problems in the last year.

I have not received a live vaccine within the last 30 days.

Treatment Details

Interventions

• Pembrolizumab (Monoclonal Antibodies)
• Pembrolizumab/Vibostolimab Co-Formulation (Monoclonal Antibodies)

Trial Overview The study tests the safety and effectiveness of a drug combo called pembrolizumab/vibostolimab (MK-7684A), alone or with other cancer therapies. It aims to see if this combination works better than pembrolizumab alone in treating participants with cervical cancer by looking at response rates and survival without progression.

Participant Groups

Group I: Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab Experimental Treatment 5 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as local standard of care (SOC) background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab.

Group II: Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel Experimental Treatment 3 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Paclitaxel.

Group III: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort) Experimental Treatment 3 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or lenvatinib 8 mg (BW \<60 kg) qd up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib.

Group IV: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort) Experimental Treatment 3 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib.

Group V: Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin Experimental Treatment 3 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Gemcitabine/Cisplatin

Group VI: Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin Experimental Treatment 3 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Capecitabine/Oxaliplatin.

Group VII: Pembrolizumab/Vibostolimab Co-Formulation Experimental Treatment 2 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy.

Group VIII: Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin Experimental Treatment 4 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with 5-Fluorouracil + Cisplatin.

Group IX: Pembrolizumab Experimental Treatment 1 Intervention

Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University