MK-7684A for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+82 other 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.

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 cancer is advanced and cannot be surgically removed.

My cervical cancer is one of the following types: squamous, adenosquamous, or adenocarcinoma.

My cancer is in the esophagus or where my stomach meets my esophagus.

I have been diagnosed with liver cancer (HCC).

I have been diagnosed with head and neck squamous cell carcinoma.

My cancer can be measured using standard imaging tests.

My cancer in the bile ducts or gallbladder cannot be removed by surgery.

Exclusion Criteria

I have both hepatitis B and C.

I am currently on medication for an infection.

I have had a transplant of an organ or tissue from another person.

I have been treated for an autoimmune disease in the last 2 years.

I have previously been treated with specific immune therapy drugs.

Participant Groups

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.

9Treatment groups

Experimental Treatment

Group I: Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/BevacizumabExperimental Treatment5 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 + PaclitaxelExperimental Treatment3 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 Treatment3 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 Treatment3 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/CisplatinExperimental Treatment3 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/OxaliplatinExperimental Treatment3 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-FormulationExperimental Treatment2 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 + CisplatinExperimental Treatment4 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: PembrolizumabExperimental Treatment1 Intervention

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

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: