Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)

  • STATUS
    Recruiting
  • End date
    Aug 27, 2023
  • participants needed
    60
  • sponsor
    Matthew Dallos
Updated on 27 January 2021
prostatectomy
gonadotropin
cancer
testosterone
prostate specific antigen
degarelix
external beam radiation therapy
adenocarcinoma
adenocarcinoma of prostate
gonadorelin

Summary

MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-sepcific antigen (PSA). The purpose of this study is to see whether immunotherapy with either Nivolumab alone or Nivolumab plus BMS-986253 combined with Degarelix, which suppresses testosterone, is safe and can decrease the chance that the cancer will come back.

The primary objectives are to 1) determine the rate of PSA recurrence defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy; and 2) determine the safety and tolerability of either nivolumab or nivolumab plus BMS-986253 in combination with degarelix in men with hormone-sensitive prostate cancer. The secondary objectives include determining relapse-free survival (RFS) and % change in PSA to immunotherapy alone.

Description

Prostate cancer is common and remains a major cause of death in men. Following local therapy with surgery or radiation, a significant number of men recur either with a rising PSA only (biochemical recurrence (BCR)) or clear metastatic disease on imaging. Although androgen deprivation therapy (ADT) is a frequently used and effective treatment for prostate cancer, it is associated with significant side effects including fatigue, hot flashes, decreased libido and bone loss. Therefore, new approaches to decrease the time on ADT are crucial to improving quality of life for men with prostate cancer.

Once initiated, ADT can be given either continuously or intermittently. However, even with an intermittent approach the ADT-free interval typically decreases with each cycle and most men eventually develop castration resistance. Therefore new treatment strategies are needed to improve disease control while minimizing ADT exposure for men with early prostate cancer.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Adenocarcinoma, Adenocarcinoma of the Prostate, Adenocarcinoma of Prostate, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Nivolumab, Degarelix, BMS-986253
Clinical Study IdentifierNCT03689699
SponsorMatthew Dallos
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Histologically confirmed adenocarcinoma of the prostate
Previously undergone primary therapy for prostate cancer (radical prostatectomy (RP) or external beam radiation (XRT) or RP + XRT). Salvage XRT following RP 6 months prior to registration is allowed
Rising PSA (two consecutive values 2.0 ng/mL above the PSA nadir taken 3 weeks apart). PSA level of 2-25 ng/mL (PSA up to 50 is allowed for patients undergoing preand on-treatment biopsies)
For the biopsy sub-groups, subjects must be willing to undergo pre- and on-treatment biopsies
PSA Doubling Time (PSADT) 12 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky score 70\
Adequate bone marrow, hepatic, and renal function
Willingness to use barrier contraception during treatment
Willingness to provide written informed consent and HIPAA authorization

Exclusion Criteria

Received any experimental immunotherapy on an experimental clinical trial 1 year prior to registration
PSA > 25 at time of enrollment (or PSA >50 for patients receiving pre- and on-treatment biopsies)
Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors
Received salvage XRT 6 months prior to registration
Received ADT 6 months prior to registration
Received any form of chemotherapy 90 days prior to registration
Received granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor (GM-CSF) 90 days prior to registration
Any major surgery requiring general anesthesia 28 days prior to registration
Any other concurrent or prior treatment for prostate cancer 28 days prior to registration
An active infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5 F or 38.1 C) within 1 week prior to registration
Prior systemic, ongoing immunosuppressive therapy 14 days prior to study treatment administration (except for adrenal replacement steroid doses 10mg daily prednisone equivalent in the absence of active autoimmune disease or a short course of steroids (<5 days) up to 7 days prior to initiating study treatment)
Prior use of experimental agents for prostate cancer
Prior participation in an anti-interleukin 8 (IL8) clinical study
A candidate is scheduled or likely to be scheduled for salvage external beam XRT or surgery for prostate cancer during the study period
Concomitant treatment with other hormonal therapy or 5-reductase inhibitors (prior use of these agents is allowed if 3 months prior to registration)
History of known or suspected autoimmune disease with the following exceptions
Asthma and/or allergic rhinitis (seasonal allergies)
Vitiligo
Resolved childhood atopic dermatitis
Psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
Residual hypothyroidism due to an autoimmune condition only requiring hormone replacement
Euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin (Ig) prior to the first dose of study treatment)
Type 1 diabetes mellitus
History of malignancy within the last 2 years (except non-melanoma skin cancers and superficial bladder cancer) and for which no additional therapy is required or anticipated to be required during the study period
Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
Known prior or current history of HIV and/or hepatitis B/C
Prior organ allograft
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