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PD-1 Inhibitor

Immunotherapy for Cancer

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically-documented, advanced solid tumor of specified types

Progression of tumor or intolerance to therapies known to provide clinical benefit

Must not have

Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment

Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of study Day 1 or not recovered from adverse events caused by a previously administered agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 10.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immunotherapy drug for people with advanced cancer who have progressed on standard of care therapy.

Who is the study for?

This trial is for adults with advanced solid tumors that have worsened after standard treatments. They must have a specific type of tumor, be able to provide tissue samples, and have measurable disease. Participants should be relatively active (ECOG 0 or 1), expected to live at least 3 months, and have good organ function. Women who can bear children must use contraception.

What is being tested?

The study tests pembrolizumab in patients with various unresectable or metastatic solid tumors that haven't responded well to existing therapies. The goal is to see how effective this drug is on different types of cancer by monitoring the participants' responses.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), liver issues, and could potentially worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed by lab tests and is an advanced solid tumor.

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My cancer has worsened or I can't tolerate my current treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I haven't taken steroids or immunosuppressants in the last 7 days.

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I haven't had cancer treatment or still have side effects from the last one within the past 2 weeks.

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I have or had lung inflammation that needed steroids.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.

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I have not received a live vaccine in the last 30 days.

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I have active brain metastases or cancer in the lining of my brain.

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I have not been in a study or taken drugs targeting immune system checkpoints.

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I have an active Hepatitis B or C infection.

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I have an active tuberculosis infection.

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I have received an organ or tissue transplant from another person.

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I am currently being treated for an infection.

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I have been diagnosed with a specific brain tumor in the brain stem.

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I have been diagnosed with HIV.

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I have been treated for an autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 10.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 10.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 10.5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Percentage of Participants who Discontinue Study Intervention due to AEs

+2 more

Side effects data

From 2024 Phase 3 trial • 453 Patients • NCT03062358

36%

Aspartate aminotransferase increased

30%

Alanine aminotransferase increased

28%

Blood bilirubin increased

21%

Platelet count decreased

18%

Gamma-glutamyltransferase increased

17%

White blood cell count decreased

17%

Pyrexia

16%

Diarrhoea

15%

Anaemia

15%

Decreased appetite

15%

Rash

14%

Blood alkaline phosphatase increased

14%

Neutrophil count decreased

12%

Hypoalbuminaemia

12%

Pruritus

11%

Cough

11%

Upper respiratory tract infection

10%

Proteinuria

10%

Hypothyroidism

10%

Lymphocyte count decreased

Constipation

Arthralgia

Weight decreased

Abdominal pain

Nausea

Bilirubin conjugated increased

Insomnia

Asthenia

Fatigue

Hyperglycaemia

Hypokalaemia

Hyponatraemia

Hypoproteinaemia

Back pain

Hypertension

Vomiting

Abdominal distension

Blood lactate dehydrogenase increased

Hyperthyroidism

Ascites

Abdominal pain upper

Hepatitis B DNA increased

Malaise

Blood glucose increased

Blood creatinine increased

Upper gastrointestinal haemorrhage

Pneumonia

Dyspepsia

Gastrointestinal haemorrhage

Autoimmune hepatitis

Hepatic failure

Hepatitis E

Influenza

Sepsis

Tumour haemorrhage

Hepatic encephalopathy

Pneumonitis

Dysphonia

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab (First Course) + BSC

Placebo + BSC

Pembrolizumab Second Course

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: Pembrolizumab 400 mgExperimental Treatment1 Intervention

Participants with any advanced solid tumor that has failed at least one line of therapy and is Tumor- Mutational Burden-High (TMB-H), excluding participants with mismatch repair deficient (dMMR/MSI-H) tumors. The dosing regimen for this cohort will be 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to approximately 2 years of treatment).

Group II: Pembrolizumab 200 mgExperimental Treatment1 Intervention

Participants will receive pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years of treatment).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5890

0 / 17Eligibility criteria met