MK-4700 + Pembrolizumab for Cancer

Recruiting at 5 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Antiretroviral therapy

Disqualifiers: Kaposi's sarcoma, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Up to 2 years

82 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain types of cancer.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors who have tried, can't tolerate, or refused all other treatments. It's open to those with specific cancers like HNSCC, melanoma, NSCLC, cervical cancer, TNBC, UC, or RCC. Participants must have well-controlled HIV if infected and normal heart function.

Inclusion Criteria

My advanced cancer has been confirmed by tests, and I've tried or can't take all beneficial treatments.

I have one of the specified types of cancer.

I have HIV and it is well controlled with medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of MK-4700 every three weeks for a maximum of 35 cycles (approximately 2 years). Eligible participants may cross over to receive MK-4700 and pembrolizumab combination therapy.

Up to 2 years

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MK-4700
• Pembrolizumab

Trial Overview The study tests different doses of MK-4700 alone or combined with Pembrolizumab to find a safe and tolerable dose that might help treat certain cancers. Researchers will observe how the body reacts over time to these treatments.

Participant Groups

Group I: Arm 2: MK-4700 + Pembrolizumab Experimental Treatment 2 Interventions

Participants will receive MK-4700 and pembrolizumab Q3W for up to 35 cycles (approximately 2 years) or until PD, death, toxicity, or withdrawal of consent.

Group II: Arm 1: MK-4700 Experimental Treatment 1 Intervention

Participants receive escalating doses every three weeks (Q3W) of MK-4700 for a maximum of 35 cycles (approximately 2 years; cycles are 21 days in length). Eligible participants enrolled in Arm 1 who experience progressive disease (PD) may cross over to Arm 2 to receive MK-4700 and pembrolizumab combination therapy.

Who Is Running the Clinical Trial?

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