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Hormone Therapy
Nivolumab + Docetaxel + ADT for Metastatic Prostate Cancer
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Number of participants with severe adverse events as assessed by CTCAE v5.0
Objective response rate
Overall survival rate
+4 moreTrial 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
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 III: COHORT 1: DNA damage repair defects (DDRD) +/- Inflamed TumorExperimental 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen Deprivation Therapy
2008
Completed Phase 2
~110
Docetaxel
1995
Completed Phase 4
~5620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Xiao X. Wei, MDLead Sponsor
Xiao X. WeiLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,972 Total Patients Enrolled
42 Trials studying Prostate Cancer
5,447 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to docetaxel, nivolumab, or LHRH analogues.I am taking oral dexamethasone before my docetaxel treatment.I have not had hormone therapy, chemotherapy, or immunotherapy for prostate cancer.I am using steroids that are inhaled, nasal, topical, or injected into joints.I have had a bone marrow or organ transplant from another person.I have HCV antibodies but no active HCV infection.I can understand and am willing to sign the consent form myself or have someone legally authorized to do so on my behalf.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I can have radiation for cancer spread before or during the study treatment.I have had cancer before, but it was a different type.I have mild nerve issues without pain, just tingling or less reflexes.My underactive thyroid condition is stable with medication.I have not taken second-generation hormonal drugs like abiraterone.I can have prostate radiation before, during, or after joining the study if a biopsy is done first.I have been treated with a PD-1 or PD-L1 inhibitor before.I had skin cancer (not melanoma) treated and currently show no signs of it.I have or had an autoimmune or inflammatory disorder.I haven't taken immunosuppressive drugs in the last 14 days, except for allowed exceptions.I was diagnosed with advanced prostate cancer less than 6 months ago.I passed the ImmunoProfile test but failed the OncoPanel test and may be placed in Cohort 2 or 3, depending on my results and DDRD status.My biopsy sample meets the specific requirements for the OncoPanel test.My limited physical ability is due to metastatic prostate cancer.I can provide a biopsy with high cancer involvement for testing.I can provide a specific tissue sample for testing.My metastatic cancer tissue can be used for OncoPanel analysis if prostate biopsy tissue is insufficient.My organs and bone marrow are functioning well.I have enough prostate biopsy tissue available for detailed analysis.My cancer has specific genetic changes confirmed by tests.My tumor is identified as having high microsatellite instability or is mismatch repair deficient.I have a skin condition that doesn't need treatment with pills or injections.I was not excluded from the trial due to unsuccessful prescreening or full cohorts.My cancer has specific genetic changes identified by a test called OncoPanel.My cancer was treated with the goal of cure, and I've been free of active disease for 2+ years.I haven't had major surgery in the last 4 weeks.My tumor lacks DDRD, is PD-L1 negative, and has low CD8+ T cell levels.My cancer has specific genetic features (DDRD or MMR-d/MSI-H) identified by a certified lab.My testosterone level before starting hormone therapy is not known, but I have discussed this with the study leader.I do not have brain metastases.My cancer has a PD-L1 score of 1 or higher.I have stopped taking antiandrogens before joining the study.My kidney function, measured by creatinine levels, is within the required range.My cancer has spread to 4 or more bones or to my organs.I am taking a low dose of steroids, not more than 10mg/day of prednisone or its equivalent.I had hepatitis B in the past but it's resolved now.I have not had surgery to remove my prostate.I have vitiligo or alopecia.I started hormone therapy for cancer and can begin the study treatment within 4 months.I do not have HIV/AIDS or I am not on antiretroviral therapy.My cancer tissue samples come from a prostate biopsy, TURP, TURBT with prostate cancer spread, or a metastatic biopsy excluding bone and lymph nodes.I can provide tissue samples with a high amount of cancer cells for study.I am a man who will use contraception during and 7 months after the study if my partner can bear children.I do not have active infections like TB, hepatitis B, or hepatitis C.My cancer's biomarkers were analyzed and fit a study group.My cancer involves changes in specific genes like BRCA1 or BRCA2.I started hormone therapy for cancer less than 120 days ago.My cancer has spread to distant parts of my body, including possibly the bones or other organs.I take steroids before certain tests due to allergies.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My tumor is PD-L1 positive or has CD8+ T cell inflammation without DDRD, placing me in Cohort 2.
Research Study Groups:
This trial has the following groups:- Group 1: COHORT 1: DNA damage repair defects (DDRD) +/- Inflamed Tumor
- Group 2: COHORT 2: Inflamed Tumor without DNA repair defects (DDRD)
- Group 3: COHORT 3: Biomarker Negative
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Androgen Deprivation Therapy been cleared by the FDA?
"Androgen Deprivation Therapy is a Phase 2 clinical trial, meaning that while there is some evidence of its safety, none for its efficacy."
Answered by AI
For what purpose is Androgen Deprivation Therapy most commonly employed?
"Androgen Deprivation Therapy is a course of treatment for metastatic bladder cancer. Additionally, this form of therapy can be used to address other conditions such as small cell lung cancer (sclc), advance directives, and malignant neoplasms."
Answered by AI
How many medical participants are joining this clinical trial?
"That is correct, the information available on clinicaltrials.gov indicates that this study is still looking for enrollees. The trial was first posted on May 11th, 2020 and was last updated on April 4th, 2022. They are hoping to enroll 60 patients at 6 different hospitals or clinics."
Answered by AI
Are there any other existing studies that Androgen Deprivation Therapy has been a part of?
"At this time, there are 1169 clinical trials ongoing that concern Androgen Deprivation Therapy. Out of these, 241 trials are in Phase 3. Although the majority of Androgen Deprivation Therapy studies are based in Duarte, California, there are 67526 total locations running trials for Androgen Deprivation Therapy."
Answered by AI
Are there any unfilled openings for volunteers in this clinical trial?
"Yes, this is an active recruitment according to the latest information on clinicaltrials.gov. The posting date was May 11th 2020 and the most recent edit was on April 4th 2022. They are looking for a total of 60 individuals across 6 sites."
Answered by AI
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