Study on Pembrolizumab for Treating Rare Tumors That Cannot Be Surgically Removed or Have Spread

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02721732

Provider View

This clinical trial is exploring how well the drug pembrolizumab works in treating patients with rare tumors that cannot be removed by surgery or have spread to other parts of the body. Pembrolizumab is a type of monoclonal antibody that may help the immune system control tumor growth.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of pembrolizumab in patients with rare tumors that cannot be surgically removed or have metastasized. Pembrolizumab is a monoclonal antibody that may block specific proteins on white blood cells, potentially strengthening the immune system to control tumor growth.

Description

The main goal of this study is to see how many patients are alive and have not experienced tumor growth 27 weeks after starting treatment with pembrolizumab. Researchers will also look at how the size of the tumors relates to a specific protein called PD-L1 and assess the safety of pembrolizumab. They will evaluate how many patients have a complete or partial response to the treatment, how long they live without the disease getting worse, and their overall survival.

The study will also explore the role of immune markers in predicting how well the treatment works and examine changes in the tumor's genetic makeup. Patients will receive pembrolizumab through an IV every 21 days for up to 24 months, as long as the disease does not progress or cause severe side effects. If patients respond well or their disease stabilizes, they may continue treatment for an additional 12 months.

After finishing the treatment, patients will have follow-up visits 30 days later and then every 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Be willing and able to provide written consent for the trial.
  • Have measurable disease based on specific criteria, with some exceptions for certain tumor types.
  • Have one of the following advanced tumors that have progressed after standard treatments: skin squamous cell carcinoma, non-pulmonary small cell malignancies, adrenocortical carcinoma, medullary renal cell carcinoma, carcinoma of unknown primary, penile carcinoma, vascular sarcoma, germ cell tumor, paraganglioma-pheochromocytoma, or other rare tumors.
  • Have failed prior treatment within 6 months of consent.
  • Have a tumor that can be biopsied, with some exceptions for certain tumor types.
  • Be willing to provide a tissue sample, either archival or newly obtained.
  • Have a performance status of 0 or 1 on the ECOG scale.
  • Meet specific blood count and organ function criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 120 days after the last dose.
  • Men must agree to use contraception during the study and for 120 days after the last dose.
  • For certain tumor types, confirmation of no brain metastases is required.

Exclusion Criteria

  • Currently receiving other cancer treatments or participating in another study.
  • Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
  • Have a history of active tuberculosis.
  • Have an allergy to pembrolizumab or its ingredients.
  • Have not recovered from side effects of previous treatments.
  • Have another progressing or active cancer, with some exceptions.
  • Have active brain metastases or carcinomatous meningitis, with some exceptions for stable brain metastases.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have active non-infectious pneumonitis.
  • Have an active infection requiring treatment.
  • Have a condition that might interfere with the study.
  • Have psychiatric or substance abuse disorders affecting participation.
  • Are pregnant or breastfeeding.
  • Have received prior therapy with similar drugs.
  • Have a history of HIV or active hepatitis B or C.
  • Have received a live vaccine within 30 days of starting the study.
  • Are in a specific cohort with certain excluded tumor types.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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