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Androgen Deprivation Therapy

Phase 2

Hormone Sensitive Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 27, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

Androgen Deprivation Therapy · 1 trial · 3 indications

Phase 2 1
NCT04126070Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed TumorsHormone Sensitive Prostate Cancer
ACTIVE NOT_RECRUITING47 Analytics
PHASE2ACTIVE NOT_RECRUITING
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
Hormone Sensitive Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Subjects With Prostate Specific Antigen (PSA) Less Than or Equal to 0.2 ng/mL at 7 Months From Start of Chemoimmunotherapy
7 months from the start of chemoimmunotherapy

Summarized as percentage with 80% two-sided exact binominal confidence interval (CI) for each cohort

Secondary Endpoints

Percentage of Subjects With PSA Less Than or Equal to 0.2 ng/mL During the Chemoimmunotherapy Combination
From the start of chemoimmunotherapy until the end of treatment or initiation of new anti-cancer therapy, whichever occurred first, for a maximum duration of 2 years.
Best Objective Response Rate in Subjects With Measurable Disease Per RECIST 1,1 Criteria
From the start of chemoimmunotherapy until the end of treatment or initiation of new anti-cancer therapy, whichever occurred first, for a maximum duration of 2 years.
Overall Survival Rate at 3-years
Time from the start of chemoimmunotherapy to death due to any cause, or censored at date last known alive, up to 3-years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
COHORT 1: DNA damage repair defects (DDRD) +/- Inflamed TumorEXPERIMENTALAfter 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.
COHORT 2: Inflamed Tumor without DNA repair defects (DDRD)EXPERIMENTALAfter 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.
COHORT 3: Biomarker NegativeEXPERIMENTALAfter 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

Interventions

NameTypeDescription
Androgen Deprivation TherapyDRUGGiven 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.
NivolumabDRUGGiven 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.
DocetaxelDRUGGiven once every 3 weeks intravenously at pre determined dosage for cycle 1-6.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Newly diagnosed histologically confirmed prostate adenocarcinoma within 6 months prior to study registration with evidence of high-volume distant metastasis on conventional imaging * Distant metastasis is defined by non-regional lymph node(s) metastasis (M1a), bone metastasis ...

Countries:United States
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Frequently asked questions about Androgen Deprivation Therapy

What is Androgen Deprivation Therapy used for in Hormone Sensitive Prostate Cancer?

Androgen Deprivation Therapy is used for Hormone Sensitive Prostate Cancer, including prostate adenocarcinoma and metastatic prostate adenocarcinoma. It is being studied in combination with other agents in a clinical trial for patients with these conditions.

Who makes Androgen Deprivation Therapy?

Androgen Deprivation Therapy is being developed by Bristol-Myers Squibb Company, traded on the stock exchange under the ticker BMY. The company is conducting a Phase 2 clinical trial for this therapy in Hormone Sensitive Prostate Cancer.

What phase is Androgen Deprivation Therapy in?

Androgen Deprivation Therapy is in Phase 2 clinical development. It is an investigational therapy for Hormone Sensitive Prostate Cancer and is not yet approved by regulatory authorities. The ongoing trial is active but not recruiting participants.

What clinical trials is Androgen Deprivation Therapy in?

Androgen Deprivation Therapy is being studied in the clinical trial NCT04126070, titled 'Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors'. This Phase 2 trial is active but not recruiting, with an enrollment of 47 participants in the United States.

Is Androgen Deprivation Therapy a small molecule?

Yes, Androgen Deprivation Therapy is classified as a small molecule modality. It is being evaluated in the oncology therapeutic area for the treatment of Hormone Sensitive Prostate Cancer.