MK-4830 + Pembrolizumab for Cancer

No longer recruiting at 41 trial locations
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No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment that combines MK-4830 (an experimental treatment) with pembrolizumab and sometimes other drugs. The goal is to determine the safety and effectiveness of this combination for various cancers, such as lung, ovarian, and breast cancers. The trial consists of several parts, each examining different doses and combinations to identify the most effective approach. Individuals with advanced cancers that have not responded to other treatments might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, radiation, or biological cancer therapy within 4 weeks before starting the trial, and you must not be taking chronic systemic steroids in doses greater than 10 mg daily of prednisone or equivalent within 7 days prior to the first dose of trial treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that MK-4830, whether used alone or with pembrolizumab, is generally safe for patients with advanced solid tumors. This combination has a manageable safety profile, meaning it usually doesn't cause severe side effects for most patients. Early studies confirmed its safety, even at different doses, which reassures those considering joining a trial.

Pembrolizumab, often used with other treatments, has a well-established safety record. It has been tested in many trials and conditions, consistently showing safe results. While side effects can occur, they are usually known and manageable.

In summary, previous studies have shown that both MK-4830 and pembrolizumab are well-tolerated. Participants can expect a reasonable safety profile, with typically manageable side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about MK-4830 combined with pembrolizumab because it introduces a novel action mechanism by targeting the immune checkpoint pathways, potentially enhancing the immune system's ability to fight cancer. Unlike traditional chemotherapy, which attacks rapidly dividing cells, this combination aims to activate the body's own defenses against cancer cells. MK-4830 specifically targets the ILT4 receptor, which may suppress tumor growth and improve outcomes for patients with various advanced cancers. This innovative approach offers hope for more effective and personalized cancer treatment strategies.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that combining MK-4830 with pembrolizumab has promising effects against tumors in patients with advanced solid cancers. In this trial, participants will receive different combinations of MK-4830 and pembrolizumab. Some arms will also include additional treatments such as paclitaxel, carboplatin, pemetrexed, or lenvatinib, depending on the specific cancer type under study. Pembrolizumab alone is already known to extend survival in cancers like lung cancer and melanoma by boosting the immune system to fight cancer cells. The combination with MK-4830 aims to enhance this effect by targeting a specific part of the immune system. Early results suggest this combination could be effective for various cancers, but further research is needed to confirm these findings.14678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with various advanced solid tumors, including specific types such as pancreatic adenocarcinoma, renal cell cancer, and non-small-cell lung cancer. Participants must have tried certain treatments without success or be ineligible for them. They should have measurable disease, adequate organ function, and agree to contraception if applicable.

Inclusion Criteria

I have high-grade ovarian, fallopian, or peritoneal cancer, have had treatment before, my cancer has worsened, and I can receive paclitaxel.
I have triple-negative breast cancer that's either inoperable, locally recurrent, or untreated and metastatic. I've also been treated with anthracycline.
I am Chinese, living in China, with advanced cancer and have tried up to 2 treatments.
See 20 more

Exclusion Criteria

I am currently being treated for an infection.
I have serious heart problems, including recent heart attacks or severe heart failure.
Has a known active hepatitis B or C
See 26 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Evaluation of safety, tolerability, and preliminary efficacy of MK-4830 monotherapy and in combination with pembrolizumab

Up to 24 months
Every 3 weeks (Q3W) for up to 35 cycles

Dose Expansion

Evaluation of objective response rate (ORR) and safety of MK-4830 in combination with pembrolizumab and other therapies

Up to 24 months
Every 3 weeks (Q3W) for up to 35 cycles

Coformulation

Evaluation of safety and tolerability of MK-4830A (coformulation of MK-4830 and pembrolizumab)

Up to 24 months
Every 3 weeks (Q3W) for up to 35 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Cisplatin
  • Lenvatinib
  • MK-4830
  • MK-4830A
  • Paclitaxel
  • Pembrolizumab
  • Pemetrexed
Trial Overview The study tests MK-4830 alone and combined with Pembrolizumab in treating advanced tumors. It includes dose escalation to assess safety and preliminary efficacy; dose expansion to evaluate response rates; plus a coformulation part testing a mix of MK-4830 and Pembrolizumab.
How Is the Trial Designed?
17Treatment groups
Experimental Treatment
Group I: Dose Expansion, Arm M: Advanced Solid Tumor in Chinese Participants In ChinaExperimental Treatment2 Interventions
Group II: Dose Expansion, Arm L: MesotheliomaExperimental Treatment4 Interventions
Group III: Dose Expansion, Arm K: Triple negative Breast Cancer (TNBC)Experimental Treatment3 Interventions
Group IV: Dose Expansion, Arm J: Ovarian CancerExperimental Treatment3 Interventions
Group V: Dose Expansion, Arm I: R/M Gastric/GE Junction AdenocarcinomaExperimental Treatment2 Interventions
Group VI: Dose Expansion, Arm H: RCC, +LenvatinibExperimental Treatment3 Interventions
Group VII: Dose Expansion, Arm G: NSCLC, +Carboplatin/PemetrexedExperimental Treatment4 Interventions
Group VIII: Dose Expansion, Arm F: First-Line Advanced NSCLC, Dose BExperimental Treatment2 Interventions
Group IX: Dose Expansion, Arm E: First-Line Advanced NSCLC, Dose AExperimental Treatment2 Interventions
Group X: Dose Expansion, Arm D: PD-L1 positive HNSCC, Dose AExperimental Treatment2 Interventions
Group XI: Dose Expansion, Arm C: R/M HNSCCExperimental Treatment2 Interventions
Group XII: Dose Expansion, Arm B: Glioblastoma (GBM)Experimental Treatment2 Interventions
Group XIII: Dose Expansion, Arm A: Pancreatic AdenocarcinomaExperimental Treatment2 Interventions
Group XIV: Dose Escalation, Part C: MK-4830 and PembrolizumabExperimental Treatment2 Interventions
Group XV: Dose Escalation, Part B: MK-4830 MonotherapyExperimental Treatment1 Intervention
Group XVI: Dose Escalation, Part A: MK-4830 MonotherapyExperimental Treatment1 Intervention
Group XVII: Coformulation Phase, Arm N: MK-4830A (Coformulation of MK-4830 + pembrolizumab)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

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 profile image

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

Published Research Related to This Trial

Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.
In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.
In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma.Hersey, P., Gowrishankar, K.[2017]

Citations

NCT03564691 | Study of MK-4830 as Monotherapy and in ...This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation.
Abstract CT104: Results from a phase 1 study of the anti ...The anti-ILT4 IgG4 monoclonal antibody MK-4830 + pembrolizumab (pembro) had a manageable safety profile and demonstrated promising antitumor activity.
524O Initial results of a phase I study of MK-4830, a first-in- ...Durable responses were observed with both MK-4830 alone and with MK-4830 + pembro in heavily pretreated pts, 5 of whom progressed on prior anti–PD-1 therapies.
Targeting ILT4 to Improve Immunotherapy Efficacy in Solid ...Among them, 50 patients received MK-4830 monotherapy, and 34 received combination therapy of MK-4830 and pembrolizumab. Analysis of the baseline ...
First-in-Class Anti-immunoglobulin–like Transcript 4 ...The intriguing data from this study support the further development of MK-4830 in combination with pembrolizumab for patients with advanced solid tumors and the ...
First-in-Class Anti-immunoglobulin–like Transcript 4 Myeloid ...MK-4830 plus pembrolizumab was well tolerated and elicited antitumor activity in patients with pretreated advanced solid tumors, including those whose disease ...
Merck Presents Promising New Data for Three ...Findings showed that MK-4830 as monotherapy and in combination with KEYTRUDA had an acceptable safety profile and demonstrated dose-related ...
Circulating tumor DNA (ctDNA) monitoring in participants ...In a phase 1 study (NCT03564691), ILT4 inhibitor MK-4830 + pembro had a manageable safety profile and showed antitumor activity in pts with ...
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