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Immune Checkpoint Inhibitors

Antineoplastic Agents, Hormonal

Hormone Antagonists

After the screening procedures confirm participation in the research study. The participant will be given a study calendar for this trial.

* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage
* Docetaxel: Given once every 3 weeks intravenously at pre-determined dosage for cycle 1-6.

After the screening procedures confirm participation in the research study. The participant will be given a study calendar for this trial.

* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage
* Docetaxel: Given once every 3 weeks intravenously at pre-determined dosage for cycle 1-6

Given per standard care for duration of study. Regimens include Leuprolide (Lupron Depot) intramuscularly every 3 months, Goserelin acetate (Zoladex) subcutaneously every 4 weeks, or degarelix (Firmagon) subcutaneously every month per standard of care.

Androgen Deprivation Therapy

Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage; up to 28 cycles total.

Given once every 3 weeks intravenously at pre determined dosage for cycle 1-6.

Xiao X Wei, MD

This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The names of the study drugs involved in this study are:

* Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon).
* Docetaxel
* Nivolumab

This research study is a Phase 2 clinical trial. Phase 2 clinical trials test the safety and effectiveness of investigational drug(s) to learn whether the drug(s) work in treating a specific disease. "Investigational" means that the drug(s) are being studied.

The U.S. Food and Drug Administration (FDA) has not approved nivolumab for hormone sensitive prostate cancer. However, nivolumab has been approved for other uses, including for advanced melanoma, lung cancer, head and neck cancer, kidney cancer, and bladder cancer.

The U.S. FDA has not approved docetaxel as a treatment option for hormone sensitive prostate cancer. However, docetaxel is approved for advanced hormone resistant prostate cancer and other cancers. There is also evidence from a high quality, phase 3 randomized clinical trial supporting the use of docetaxel in metastatic hormone sensitive prostate cancer patients who have a high burden of metastasis. Docetaxel is an off-label indication for hormone sensitive prostate cancer.

The U.S. FDA has approved androgen deprivation therapy (ADT) agents, including leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon), as a treatment option for hormone sensitive prostate cancer.

The combination of ADT, also called hormonal therapy, with docetaxel chemotherapy and nivolumab immunotherapy is considered investigational. ADT cuts off the supply of testosterone and is the standard of care for hormone sensitive prostate cancer. The addition of docetaxel chemotherapy has been found to prolong life for prostate cancer patients starting hormonal therapy for the first time for metastatic disease, who also have a large volume of cancer.

Another anti-cancer treatment modality is called immunotherapy. The immune system can kill cells that are recognized as different or dangerous, such as infected cells and cancer cells. Nivolumab is an antibody (a type of human protein) that work to stimulate the body's immune system to recognize and fight cancer cells.

Hormonal therapy and chemotherapy may make cancer cells more recognizable to the immune system, and make cancer cells more susceptible to immunotherapy. The goal of this study is to examine the activity and safety of hormonal therapy combined with docetaxel chemotherapy and nivolumab immunotherapy for hormone sensitive prostate cancer. The study is designed to enrich for patients whose tumors may be more most responsive to this treatment strategy. All patients will receive the same treatment of ADT combined with docetaxel chemotherapy and nivolumab immunotherapy.

Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors

A Phase 2 Multicohort Study of Nivolumab in Combination With Docetaxel and Androgen Deprivation Therapy in Metastatic Hormone Sensitive Prostate Cancer Patients With DNA Damage Repair Defects or Inflamed Tumors

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Summarized with 80% two-sided exact binominal confidence interval (CI)

95% two-sided exact binomial CI (per RECIST 1.1 criteria)

Kaplan-Meier methodology Defined as the time from registration to date of documented clinical progression, defined by increasing symptomatic bony metastasis, progression per RECIST 1.1 criteria, or clinical deterioration due to cancer based on investigator's judgment.

Kaplan-Meier methodology Time from registration to the date of documented at least 50% increase in serum PSA, with the lowest PSA level (nadir)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors	NCT04126070	Hormone Sensiti... Prostate Adenoc... Metastasis Pros...	Androgen Depriv... Nivolumab Docetaxel	18 Years -	Dana-Farber Cancer Institute
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors	NCT04126070	Hormone Sensiti... Prostate Adenoc... Metastasis Pros...	Androgen Depriv... Nivolumab Docetaxel	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for metastasis prostate adenocarcinoma