Study on Androgen Deprivation Therapy and Pembrolizumab for Advanced Androgen Receptor-positive Salivary Gland Cancer

Sponsor: Manish Patel

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03942653

Provider View

This clinical trial is exploring a combination of hormone therapy and an immunotherapy drug, pembrolizumab, to treat advanced salivary gland cancer that cannot be treated with surgery or radiation. The study aims to see if this combination can help control the cancer.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with advanced salivary gland cancer that has spread or returned and cannot be treated with surgery or radiation. The treatment combines hormone therapy (ADT) with the immunotherapy drug pembrolizumab. The study will include patients who have not received previous systemic therapy and those whose cancer did not respond to previous treatments. However, patients who have had previous hormone therapy or immunotherapy will not be eligible. The treatment involves regular injections of goserelin acetate and pembrolizumab, with the goal of continuing treatment for up to 35 cycles unless the cancer progresses or side effects become too severe. The study will monitor the cancer's response through regular scans and blood tests.

Description

This clinical trial is designed to test a combination of hormone therapy (ADT) and the immunotherapy drug pembrolizumab for patients with advanced salivary gland cancer that cannot be treated with surgery or radiation. The study will include patients who have not received previous systemic therapy and those whose cancer did not respond to previous treatments. However, patients who have had previous hormone therapy or immunotherapy will not be eligible.

The treatment involves:

  • Goserelin acetate injections every 4 weeks, starting about 2 weeks before the first dose of pembrolizumab.
  • Pembrolizumab 200 mg given every 21 days, starting 2 weeks after the first goserelin acetate injection.
  • Treatment will continue for up to 35 cycles, unless the cancer progresses, side effects become too severe, or the patient chooses to stop.

The study will use a two-stage design to evaluate the treatment's effectiveness. Initially, 9 patients will be enrolled, and if at least 2 show a positive response, an additional 11 patients will be added, aiming for a total of 20 patients. If fewer than 4 out of 20 patients respond, the treatment will not be considered effective.

Patients will undergo regular scans of the neck, chest, abdomen, and pelvis every 12 weeks to monitor the cancer's response. Tumor samples will be collected at the start of the study to check for specific markers, and an optional biopsy may be done after 4 doses of pembrolizumab to assess the immune response. Blood samples will also be collected at various points to evaluate changes in immune cells.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization for the release of personal health information.
  • Must be 18 years or older.
  • Have advanced salivary gland cancer that cannot be treated with surgery or radiation.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Cancer must be confirmed as androgen receptor-positive.
  • Have measurable disease according to specific criteria.
  • If previously treated, must show disease progression on prior therapy.
  • Previous chemotherapy, radiation, or surgery is allowed if not involving hormone or immune therapy.
  • Must have recovered from previous cancer treatment side effects.
  • Must have adequate organ function based on specific blood tests.
  • Male participants must agree to use contraception during treatment and for 8 months after.
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception during treatment and for 8 months after.
  • Must be able to understand and comply with study procedures.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have received previous PD-1, PD-L1, or PD-L2 inhibitors or similar immune therapies.
  • Have received previous hormone therapy for cancer.
  • Have received systemic anti-cancer therapy within 14 days before the study.
  • Have had a tissue or organ transplant.
  • Have received recent palliative radiotherapy.
  • Have received a live vaccine within 28 days before the study.
  • Have an immune deficiency or are on high-dose steroids or immunosuppressive therapy.
  • Have another progressing cancer or required treatment in the past 2 years.
  • Have active brain metastases or meningitis.
  • Have severe allergies to pembrolizumab.
  • Have active autoimmune disease requiring treatment in the past 2 years.
  • Have a history of lung disease requiring steroids.
  • Have an active infection needing treatment.
  • Have a history of HIV or active tuberculosis.
  • Have any condition that might interfere with the study.
  • Have psychiatric or substance abuse disorders affecting study participation.
  • Are expecting to conceive or father children during the study and for 120 days after.

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