What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving Pembrolizumab (a PD-1 inhibitor), include fatigue, rash, itching, diarrhea, and nausea. Severe side effects can include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. When combined with chemotherapy, additional side effects may include myelosuppression, neuropathy, and increased risk of infection. The combination therapies aim to enhance anti-tumor efficacy but also come with a higher risk of compounded side effects.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has received FDA approval for the treatment of several solid tumors, including non-small cell lung cancer (NSCLC), melanoma, and gastric cancer. Other similar immune checkpoint inhibitors include Nivolumab (PD-1 inhibitor) and Atezolizumab (PD-L1 inhibitor), which have also been approved for various solid tumors. These drugs enhance the immune system's ability to target and destroy cancer cells by blocking the PD-1/PD-L1 pathway.

What other types of research exist?

Promising novel alternatives to MK-1484 for solid tumor patients include: 1) Bispecific fusion proteins targeting 4-1BB and PD-L1, which aim to enhance efficacy while reducing toxicity. 2) Next-generation compounds targeting validated molecular pathways, such as those targeting BRAF mutations in melanoma. 3) Combination therapies involving PD-1 inhibitors like pembrolizumab with other agents such as ipilimumab (CTLA-4 inhibitor) or avelumab (PD-L1 inhibitor). These alternatives are being actively researched and have shown potential in clinical trials.

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MK-1484 + 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

Has provided an evaluable archival or newly obtained tumor tissue sample for biomarker analysis.

Has normal cardiac function based on transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA).

Must not have

Has received any prior interleukin-2 (IL-2) based therapy.

Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety of MK-1484 alone and with pembrolizumab in adults with severe, spreading cancers. MK-1484 is a new drug, while pembrolizumab helps the immune system attack cancer cells.

Who is the study for?

Adults with advanced or metastatic solid tumors who have tried all other treatments or can't tolerate them are eligible. They must have measurable disease, normal heart function, and adequate organ function. Participants need to provide a tumor sample for analysis and agree to use contraception. Excluded are those with certain lung conditions, recent transplants, active infections including HIV/HBV/HCV, uncontrolled diseases or conditions that could affect the trial's outcome.

What is being tested?

The study is testing MK-1484 alone and combined with Pembrolizumab in patients with advanced solid tumors. It aims to find out how safe these treatments are and determine the best dose for Phase 2 trials.

What are the potential side effects?

While not specified here, common side effects of cancer immunotherapy like MK-1484 and Pembrolizumab may include fatigue, skin reactions, inflammation in organs such as lungs (pneumonitis), liver problems, hormonal changes affecting glands like thyroid; also possible immune system reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have given a tissue sample for cancer marker tests.

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My heart function is normal as confirmed by a heart scan.

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My advanced cancer is confirmed by tests and I've tried or can't tolerate all beneficial treatments.

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I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines for 120 days after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously received IL-2 based therapy.

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I have had or currently have lung inflammation treated with steroids.

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I have had a transplant from another person in the last 5 years or have signs of my body rejecting the transplant.

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My cancer has spread to my brain or spinal cord.

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I am currently being treated for an infection.

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I have recovered from major surgery and have no infections.

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I have a history of lung scarring or fibrosis.

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I had another cancer but was treated successfully and have been cancer-free for 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 27 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Discontinue Study Treatment Due to an AE

Number of Participants Who Experience At Least One AE

Number of Participants with a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0

Secondary study objectives

Area Under the Curve (AUC) of MK-1484

Maximum Serum Concentration (Cmax) of MK-1484

Minimum Serum Concentration (Cmin) of MK-1484

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MK-1484 + PembrolizumabExperimental Treatment2 Interventions

Participants will receive MK-1484 Q3W at escalating dose levels from 10-60 mg plus pembrolizumab 200 mg once every 21-day cycle for up to a total of 35 cycles (up to approximately 24 months).

Group II: MK-1484Experimental Treatment1 Intervention

Participants will receive MK-1484 every 3 weeks (Q3W) or 21-day cycle at escalating dose levels from 0.2-60 mg for up to a total of 35 cycles (up to approximately 24 months).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immune checkpoint inhibitors, such as PD-1 inhibitors (e.g., pembrolizumab) and CTLA-4 inhibitors (e.g., ipilimumab), enhance the immune system's ability to recognize and destroy tumor cells by blocking proteins that prevent T-cells from attacking cancer cells. This mechanism is crucial for solid tumor patients as it offers a promising approach to improve survival and response rates by leveraging the body's own immune system to combat cancer.

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