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MK-4830 + Pembrolizumab for Cancer

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Dose escalation participants: Has any histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and has received, has been intolerant to, or has been ineligible for all treatment known to confer clinical benefit. Solid tumors of any type are eligible for enrollment
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either not a woman of childbearing potential (WOCBP) OR if a WOCBP agrees to follow the study contraceptive guidance during the treatment period and for at least 180 days after the last dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new cancer drug, MK-4830, either alone or in combination with other drugs.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, potential liver or kidney issues due to organ inflammation, allergic reactions, and other immune-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an advanced cancer that has spread, and I've tried or can't try all known beneficial treatments.
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I am not pregnant or breastfeeding, and if I can have children, I agree to use contraception as advised for 180 days after the last treatment.
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My cancer in the head or neck area has returned or spread and didn't respond to platinum-based treatment.
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My cancer is in the mouth or throat and can't be cured with surgery or radiation, and I haven't had PD-1/PD-L1 therapy.
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I have advanced non-squamous NSCLC and haven't had systemic therapy for it.
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My mesothelioma has returned or spread and cannot be cured with standard treatments, but I can receive chemotherapy.
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My cancer can be measured using specific criteria.
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I have metastatic pancreatic cancer and received 1-3 prior treatments.
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My cancer can be measured using standard imaging techniques.
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I agree to use approved birth control and not donate sperm for 6 months after my last treatment.
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My cancer is a type of pancreatic cancer that has spread.
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I have advanced or recurrent kidney cancer with clear cells and haven't had systemic therapy for it.
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I have at least one cancerous lesion that can be biopsied.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs are functioning well.
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I have had 1 to 3 treatments for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-Limiting Toxicities (DLTs)
Number of Participants Who Discontinued Study Treatment Due to an AE
Number of Participants Who Experienced an Adverse Event (AE)
+2 more
Secondary outcome measures
Area Under the Curve (AUC) of Plasma MK-4830
Maximum Drug Concentration (Cmax) of Plasma MK-4830
Maximum Drug Concentration (Cmax) of Plasma Pembrolizumab in Arm M
+3 more

Trial Design

17Treatment groups
Experimental Treatment
Group I: Dose Expansion, Arm M: Advanced Solid Tumor in Chinese Participants In ChinaExperimental Treatment2 Interventions
Combination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in Chinese participants, who reside in China, have histologically or cytologically-confirmed advanced/metastatic solid tumor, and who have been previously treated with at least 2 prior lines of therapy. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group II: Dose Expansion, Arm L: MesotheliomaExperimental Treatment4 Interventions
Triple combination therapy with pembrolizumab plus preliminary RP2D A of MK-4830 plus pemetrexed plus cisplatin in participants who have histologically confirmed advanced mesothelioma. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1 for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Pemetrexed will be administered by IV, on Day 1 of each Q3W cycle for a maximum of 6 cycles. Each cycle is 21 days. Cisplatin will be administered by IV, on Day 1 of each Q3W cycle for a maximum of 6 cycles. Each cycle is 21 days.
Group III: Dose Expansion, Arm K: Triple negative Breast Cancer (TNBC)Experimental Treatment3 Interventions
Triple combination therapy with pembrolizumab plus preliminary RP2D A of MK-4830 plus paclitaxel in participants who have histologically confirmed TNBC. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1 for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Paclitaxel will be administered by IV on Days 1, 8, and 15 every 4 weeks (Q4W) until disease progression or prohibitive toxicity.
Group IV: Dose Expansion, Arm J: Ovarian CancerExperimental Treatment3 Interventions
Triple combination therapy with pembrolizumab plus preliminary RP2D A of MK-4830 plus paclitaxel in participants who have histologically confirmed, ovarian cancer. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1 for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Paclitaxel will be administered by IV, once every week (QW) on Days 1, 8, and 15 of each 21-day cycle until disease progression or prohibitive toxicity.
Group V: Dose Expansion, Arm I: R/M Gastric/GE Junction AdenocarcinomaExperimental Treatment2 Interventions
Combination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants who have histologically or cytologically-confirmed recurrent or metastatic (R/M) gastric or gastroesophageal (GE) junction adenocarcinoma and who have been previously treated with at least 2 prior lines of therapy. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group VI: Dose Expansion, Arm H: RCC, +LenvatinibExperimental Treatment3 Interventions
Combination therapy with the preliminary RP2D A of MK-4830, pembrolizumab, and lenvatinib in participants with advanced renal cell carcinoma (RCC). MK-4830 will be administered IV, Q3W, starting with Cycle 1 following pembrolizumab infusion, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years). Lenvatinib will be administered orally once daily for up to 35 cycles of 21 days (up to approximately 2 years).
Group VII: Dose Expansion, Arm G: NSCLC, +Carboplatin/PemetrexedExperimental Treatment4 Interventions
Combination therapy with the preliminary RP2D A of MK-4830, pembrolizumab, and carboplatin/pemetrexed in participants with advanced non-squamous non-small-cell-lung-cancer (NSCLC) (Stage IIIB or IV). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles. Carboplatin and pemetrexed will be administered IV Q3W, starting with Cycle 1, Day 1, for 4 cycles, followed by pemetrexed Q3W continuous with MK-4830 and pembrolizumab, up to 35 cycles. Each cycle is 21 days (up to approximately 2 years).
Group VIII: Dose Expansion, Arm F: First-Line Advanced NSCLC, Dose BExperimental Treatment2 Interventions
Combination therapy with the preliminary RP2D B of MK-4830, and pembrolizumab, in participants who have histologically-confirmed, first-line treatment advanced non-small-cell-lung-cancer (NSCLC) (Stage IIIB or IV). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group IX: Dose Expansion, Arm E: First-Line Advanced NSCLC, Dose AExperimental Treatment2 Interventions
Combination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants who have histologically-confirmed, first-line treatment advanced non-small-cell-lung-cancer (NSCLC) (Stage IIIB or IV). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group X: Dose Expansion, Arm D: PD-L1 positive HNSCC, Dose AExperimental Treatment2 Interventions
Combination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants who have histologically or cytologically-confirmed advanced programmed death-ligand 1 (PD-L1) positive head and neck squamous cell carcinoma (HNSCC). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group XI: Dose Expansion, Arm C: R/M HNSCCExperimental Treatment2 Interventions
Combination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants who have histologically or cytologically-confirmed recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease progressed on an anti-programmed cell death 1/programmed cell death ligand 1 (PD1/L1) therapy. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group XII: Dose Expansion, Arm B: Glioblastoma (GBM)Experimental Treatment2 Interventions
Combination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants with histologically or cytologically confirmed GBM. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group XIII: Dose Expansion, Arm A: Pancreatic AdenocarcinomaExperimental Treatment2 Interventions
Combination therapy with the preliminary recommended phase 2 dose (RP2D) A of MK-4830, and pembrolizumab, in participants with histologically or cytologically confirmed pancreatic adenocarcinoma. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group XIV: Dose Escalation, Part C: MK-4830 and PembrolizumabExperimental Treatment2 Interventions
Combination therapy with MK-4830 and pembrolizumab (with MK-4830 doses determined by an mTPI design). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Group XV: Dose Escalation, Part B: MK-4830 MonotherapyExperimental Treatment1 Intervention
MK-4830 monotherapy (with MK 4830 doses determined by a modified toxicity probability interval [mTPI] method) will be administered IV, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Participants enroll with histologically or cytologically confirmed pleural or peritoneal malignant mesothelioma, epithelial, sarcomatoid, or biphasic subtypes.
Group XVI: Dose Escalation, Part A: MK-4830 MonotherapyExperimental Treatment1 Intervention
MK-4830 monotherapy (with MK-4830 doses determined by an accelerated titration design [ATD]) will be administered intravenously (IV), every 3 weeks (Q3W), starting with Cycle 1, Day 1, for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Participants enroll with histologically or cytologically confirmed pancreatic adenocarcinoma.
Group XVII: Coformulation Phase, Arm N: MK-4830A (Coformulation of MK-4830 + pembrolizumab)Experimental Treatment1 Intervention
Monotherapy with MK-4830A, a coformulation of MK-4830 800 mg + pembrolizumab 200 mg, in participants with histologically or cytologically-confirmed advanced/metastatic solid tumor, and who and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit. MK-4830A will be administered IV, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Cisplatin
2013
Completed Phase 3
~1940
Pembrolizumab
2017
Completed Phase 2
~1950
Carboplatin
2014
Completed Phase 3
~6670
Lenvatinib
2005
Completed Phase 4
~2690
Pemetrexed
2014
Completed Phase 3
~5250

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,258 Total Patients Enrolled
11 Trials studying Tumors
2,324 Patients Enrolled for Tumors
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,469 Total Patients Enrolled
5 Trials studying Tumors
149 Patients Enrolled for Tumors
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,061,758 Total Patients Enrolled
2 Trials studying Tumors
34 Patients Enrolled for Tumors

Media Library

MK-4830 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03564691 — Phase 1
Tumors Research Study Groups: Dose Expansion, Arm E: First-Line Advanced NSCLC, Dose A, Dose Expansion, Arm J: Ovarian Cancer, Dose Expansion, Arm I: R/M Gastric/GE Junction Adenocarcinoma, Dose Expansion, Arm D: PD-L1 positive HNSCC, Dose A, Dose Escalation, Part A: MK-4830 Monotherapy, Dose Expansion, Arm G: NSCLC, +Carboplatin/Pemetrexed, Dose Expansion, Arm L: Mesothelioma, Dose Escalation, Part B: MK-4830 Monotherapy, Dose Escalation, Part C: MK-4830 and Pembrolizumab, Dose Expansion, Arm K: Triple negative Breast Cancer (TNBC), Dose Expansion, Arm M: Advanced Solid Tumor in Chinese Participants In China, Dose Expansion, Arm H: RCC, +Lenvatinib, Dose Expansion, Arm A: Pancreatic Adenocarcinoma, Coformulation Phase, Arm N: MK-4830A (Coformulation of MK-4830 + pembrolizumab), Dose Expansion, Arm C: R/M HNSCC, Dose Expansion, Arm B: Glioblastoma (GBM), Dose Expansion, Arm F: First-Line Advanced NSCLC, Dose B
Tumors Clinical Trial 2023: MK-4830 Highlights & Side Effects. Trial Name: NCT03564691 — Phase 1
MK-4830 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03564691 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants for this investigation?

"Affirmative, clinicaltrials.gov's information confirms that this experiment is currently recruiting individuals. The trial was first posted on July 11th 2018 and updated November 25th 2022. 442 participants need to be enrolled from 9 different medical centres."

Answered by AI

What have been the reported safety implications of Pembrolizumab administration?

"As this is a Phase 1 clinical trial, there is only limited data indicating pembrolizumab's efficacy and safety. Hence, our team at Power have rated it with a score of 1 on the scale."

Answered by AI

What is the purport of this investigation?

"Based on the information provided by Merck Sharp & Dohme Corp., this clinical trial will chiefly monitor for dose-limiting toxicities (DLTs) over a 24 month period. Secondary measurements include maximum and minimum drug concentration of plasma MK-4830, as well as its area under the curve; all samples are taken pre-, post-, or 2 hours after infusion depending on cycle length."

Answered by AI

Could you provide details on the Canadian sites that are conducting this experiment?

"Nine sites are currently offering this clinical trial: namely, The Ottawa Hospital (Site 0031) in Ottawa, Seattle Cancer Care Alliance ( Site 0010) in Seattle, and John Theurer Cancer Center at Hackensack University Medical Center (Site 0005)in Hackensack. Additionally, there are six other locations available to prospective participants."

Answered by AI

Is there still capacity to join this trial as a participant?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this medical experiment is actively seeking volunteers for participation. The trial was first posted in July 2018 and has since been updated as of November 2022, targeting 442 patients from 9 different sites."

Answered by AI

Have there been any past inquiries into the efficacy of Pembrolizumab?

"City of Hope Comprehensive Cancer Center conducted the first experiment with pembrolizumab in 1997. Since then, 2662 studies have been completed and 2394 are currently underway; many of these trials take place near Ottawa, Ontario."

Answered by AI

What indications is Pembrolizumab commonly used to treat?

"Pembrolizumab is a commonly used to combat malignant neoplasms, as well as non-resectable melanomas and microsatellite instability high. Additionally, it has been found to be effective at treating locally advanced nonsquamous non-small cell lung cancer cases."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
Seattle Cancer Care Alliance ( Site 0010)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~91 spots leftby Oct 2025