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MK-4830 + Pembrolizumab for Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am currently being treated for an infection.I have serious heart problems, including recent heart attacks or severe heart failure.I've had chemotherapy or targeted therapy for Stage IIIb/IV NSCLC and treatment with anti-PD-1/PD-L1/PD-L2.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.I have an advanced cancer that has spread, and I've tried or can't try all known beneficial treatments.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.You provide a tumor sample for analysis at the beginning of the trial. (This does not apply to a specific part of the trial called Expansion phase Arm M.)I am not pregnant or breastfeeding, and if I can have children, I agree to use contraception as per the study's guidance.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.I have advanced lung cancer and haven't had systemic therapy for it.I have advanced non-squamous NSCLC and haven't had systemic therapy for it.My mesothelioma has returned or spread and cannot be cured with standard treatments, but I can receive chemotherapy.I have had lung inflammation treated with steroids or have it now.I have or had lung disease that affects the tissue and space around the air sacs.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years, except for vitiligo or childhood asthma.My cancer does not have a high MSI status.My cancer can be measured using specific criteria.I have metastatic pancreatic cancer and received 1-3 prior treatments.My cancer can be measured using standard imaging techniques.I am allergic to the study drugs or their components, or I'm taking medication that can't be combined with the study drugs unless I stopped it 7 days before joining.I agree to use approved birth control and not donate sperm for 6 months after my last treatment.My cancer is a type of pancreatic cancer that has spread.I have advanced or recurrent kidney cancer with clear cells and haven't had systemic therapy for it.I have advanced stomach cancer, treated with at least two chemotherapies, and trastuzumab if HER2 positive.I have an advanced cancer and cannot or have not benefited from standard treatments.I have recovered from major surgery and have no infections.I have had more than 3 treatments for advanced pancreatic cancer.I have not had a live vaccine in the last 30 days.My tumor is in the brainstem or spinal cord, is larger than 6 cm, or needs steroids.I have had chemotherapy or targeted therapy for Stage IIIb/IV non-squamous NSCLC and treatment with anti-PD-1, PD-L1, or PD-L2.My cancer in the head or neck area has returned or spread and didn't respond to platinum-based treatment.I still have side effects from radiation that are not mild and I need steroids for lung inflammation.I have symptoms like cough or chest pain due to fluid in my chest and have had a transplant.I do not have untreated brain metastases or carcinomatous meningitis.I have had chemotherapy or other treatments for my advanced head and neck cancer.I have lost more than 10% of my weight in the last 2 months, have fluid in my abdomen, and cancer has spread to the lining of my abdomen.I stopped immunotherapy due to severe side effects.I have at least one cancerous lesion that can be biopsied.My organs are functioning well.I have at least one cancerous lesion that can be biopsied.I am fully active or restricted in physically strenuous activity but can do light work.You are currently taking part in a study involving an experimental medication or device, or have taken part in such a study within the last 28 days before starting this trial.I have been taking more than 10 mg of steroids daily in the last week.I had another cancer but was treated successfully and have been cancer-free for 2 years.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well.I haven't had cancer treatment in the last 4 weeks or still have side effects from treatments over 4 weeks ago.I have had 1 to 3 treatments for my condition.I have an advanced cancer that has spread, and I can't take or haven't benefited from known treatments.I've had a severe allergic reaction to monoclonal antibody treatment or am allergic to pembrolizumab or its chemotherapy components.I agree to use approved birth control and not donate sperm for 6 months after my last treatment.I have a rare ovarian cancer type and have had more than 2 treatments.
- Group 1: Dose Expansion, Arm E: First-Line Advanced NSCLC, Dose A
- Group 2: Dose Expansion, Arm J: Ovarian Cancer
- Group 3: Dose Expansion, Arm I: R/M Gastric/GE Junction Adenocarcinoma
- Group 4: Dose Expansion, Arm D: PD-L1 positive HNSCC, Dose A
- Group 5: Dose Escalation, Part A: MK-4830 Monotherapy
- Group 6: Dose Expansion, Arm G: NSCLC, +Carboplatin/Pemetrexed
- Group 7: Dose Expansion, Arm L: Mesothelioma
- Group 8: Dose Escalation, Part B: MK-4830 Monotherapy
- Group 9: Dose Escalation, Part C: MK-4830 and Pembrolizumab
- Group 10: Dose Expansion, Arm K: Triple negative Breast Cancer (TNBC)
- Group 11: Dose Expansion, Arm M: Advanced Solid Tumor in Chinese Participants In China
- Group 12: Dose Expansion, Arm H: RCC, +Lenvatinib
- Group 13: Dose Expansion, Arm A: Pancreatic Adenocarcinoma
- Group 14: Coformulation Phase, Arm N: MK-4830A (Coformulation of MK-4830 + pembrolizumab)
- Group 15: Dose Expansion, Arm C: R/M HNSCC
- Group 16: Dose Expansion, Arm B: Glioblastoma (GBM)
- Group 17: Dose Expansion, Arm F: First-Line Advanced NSCLC, Dose B
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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What portion of applicants met pre-screening criteria?
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