Long-term Safety and Effectiveness Study for Patients with Advanced Tumors on Pembrolizumab Treatment

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03486873

Provider View

This study is designed to evaluate the long-term safety and effectiveness of pembrolizumab in patients who have been part of previous studies and are continuing their treatment or follow-up.

Patient Parameters

Program Overview

The study aims to assess the long-term safety and effectiveness of pembrolizumab (MK-3475) in patients who were part of earlier studies. It includes three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Depending on the phase they were in during the previous study, participants will continue in the corresponding phase in this extension study. Those in the First Course Phase will continue receiving pembrolizumab or a combination treatment. Participants in the Follow-up Phase will continue to be monitored, while those in the Second Course Phase will receive additional doses of pembrolizumab or a combination treatment. Participants who were allowed to switch to pembrolizumab in earlier studies may receive up to 35 doses over approximately two years if their cancer progresses and pembrolizumab is approved in their country.

Eligibility Criteria

Inclusion Criteria

  • Must have been part of previous pembrolizumab studies and be ready to continue in this extension study.
  • Currently receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib, or in a follow-up phase.

For those entering the Second Course Phase:

  • No new cancer treatment since the last pembrolizumab dose in the First Course Phase.
  • Good overall health with a performance status of 0 or 1.
  • Adequate organ function.
  • Any side effects from the First Course Phase must be resolved to a mild level before starting the Second Course Phase.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception during the study and for 120 days after.

For those receiving Lenvatinib:

  • Blood pressure must be controlled to below 150/90 mmHg.
  • Male participants must agree to use contraception during the study and for 7 days after the last dose.
  • Female participants must not be pregnant or breastfeeding and must use effective contraception during the study and for 4 days after.

Exclusion Criteria

  • Severe allergy to pembrolizumab or its ingredients.
  • Received a live vaccine within 30 days before starting the Second Course Phase.
  • Have an immune deficiency or are on high-dose steroids or other immune-suppressing treatments.
  • Have another progressing cancer needing treatment, except for certain early-stage cancers.
  • Have active brain cancer or meningitis.
  • Have an autoimmune disease needing treatment in the past 2 years.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have an active infection needing treatment.
  • Have HIV, hepatitis B, or hepatitis C, unless allowed by previous study criteria.
  • Pregnant or breastfeeding, or planning to conceive during the study and for 120 days after.
  • Have severe heart disease or liver problems.
  • Have uncontrolled thyroid or diabetes issues.
  • Have had an organ transplant.
  • Have active tuberculosis.

For those receiving Lenvatinib:

  • Had major surgery within 3 weeks before starting the study.
  • Have severe gastrointestinal issues or fistulas.
  • Have significant protein in urine.
  • Have heart function below normal.
  • Have tumors affecting major blood vessels.
  • Have prolonged heart rhythm intervals.
  • Have significant heart disease within the past year.
  • Have conditions affecting lenvatinib absorption.
  • Have recent significant coughing up of blood.
  • Have severe allergy to lenvatinib.

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