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Hormone Therapy

Nivolumab + Docetaxel + ADT for Metastatic Prostate Cancer

Phase 2

Waitlist Available

Led By Xiao X Wei, MD

Research Sponsored by Xiao X. Wei, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects whose tumors harbor somatic or germline homozygous deletions and/or deleterious mutations in a DDR gene using OncoPanel will be assigned to Cohort 1, regardless of ImmunoProfile results

Newly diagnosed histologically confirmed prostate adenocarcinoma within 6 months prior to study registration with evidence of high-volume distant metastasis on conventional imaging

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), nivolumab, or LHRH analogue (e.g., leuprolide, goserelin acetate, degarelix)

Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intraarticular injection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of ADT, chemotherapy, and immunotherapy to see if it is an effective treatment for hormone-sensitive prostate cancer that has spread to other parts of the body.

Who is the study for?

Men over 18 with newly diagnosed high-volume metastatic hormone-sensitive prostate cancer, not previously treated with ADT, chemotherapy or immunotherapy. They must have a good performance status and adequate organ function. Men must agree to use contraception during the study and for 7 months after.

What is being tested?

The trial is testing a combination of hormonal therapy (ADT), chemotherapy (Docetaxel), and immunotherapy (Nivolumab) as potential treatments for advanced prostate cancer. Participants will receive these medications to see how well they work together.

What are the potential side effects?

Possible side effects include fatigue, hair loss from chemotherapy, immune-related reactions like inflammation in different body parts due to Nivolumab, skin rash, nausea, decreased appetite and changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has specific genetic changes identified by a test called OncoPanel.

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I was diagnosed with advanced prostate cancer less than 6 months ago.

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My cancer has specific genetic changes confirmed by tests.

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I was not excluded from the trial due to unsuccessful prescreening or full cohorts.

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My tumor lacks DDRD, is PD-L1 negative, and has low CD8+ T cell levels.

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My cancer has a PD-L1 score of 1 or higher.

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My kidney function, measured by creatinine levels, is within the required range.

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My cancer has spread to 4 or more bones or to my organs.

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My cancer tissue samples come from a prostate biopsy, TURP, TURBT with prostate cancer spread, or a metastatic biopsy excluding bone and lymph nodes.

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My cancer's biomarkers were analyzed and fit a study group.

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My cancer has spread to distant parts of my body, including possibly the bones or other organs.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to docetaxel, nivolumab, or LHRH analogues.

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I am using steroids that are inhaled, nasal, topical, or injected into joints.

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I have had a bone marrow or organ transplant from another person.

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I have HCV antibodies but no active HCV infection.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have had cancer before, but it was a different type.

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My underactive thyroid condition is stable with medication.

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I have not taken second-generation hormonal drugs like abiraterone.

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I have been treated with a PD-1 or PD-L1 inhibitor before.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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My cancer was treated with the goal of cure, and I've been free of active disease for 2+ years.

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I have a skin condition that doesn't need treatment with pills or injections.

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I do not have brain metastases.

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I have not had surgery to remove my prostate.

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I have vitiligo or alopecia.

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I do not have HIV/AIDS or I am not on antiretroviral therapy.

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I do not have active infections like TB, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the proportion of subjects with PSA less than or equal to 0.2 ng/mL at 7 months from start of chemoimmunotherapy in each cohort

Secondary study objectives

Objective response rate

Overall survival rate

Time to castration resistant disease

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: COHORT 3: Biomarker NegativeExperimental Treatment3 Interventions

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

Group II: COHORT 2: Inflamed Tumor without DNA repair defects (DDRD)Experimental Treatment3 Interventions

Group III: COHORT 1: DNA damage repair defects (DDRD) +/- Inflamed TumorExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Nivolumab

2015