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Immunotherapy

Testosterone cypionate for Prostate Cancer (COMBAT-CRPC Trial)

Phase 2

Waitlist Available

Led By Mark Markowski, MD, Ph.D

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

COMBAT-CRPC Trial Summary

This trial is testing whether giving testosterone and nivolumab to men with metastatic prostate cancer who have progressed on other treatments can help them.

Eligible Conditions

Prostate Cancer

COMBAT-CRPC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy + Nivolumab

Secondary outcome measures

Durable Progression-Free Survival (Durable PFS) to Bipolar Androgen Therapy + Nivolumab

Median Overall Survival (OS) to Bipolar Androgen Therapy + Nivolumab

Objective Response Rate (ORR) to Bipolar Androgen Therapy + Nivolumab

+3 more

Other outcome measures

Clinical Response Association of Bipolar Androgen Therapy + Nivolumab to Mutation-associated Neoantigens (MANAs).

Clinical Response Association to Bipolar Androgen Therapy + Nivolumab as Assessed by the Generation of Tumor-associated Neoantigens (TAAs)

Correlation of Bipolar Androgen Therapy on the Production of Inflammatory Chemokines and Cytokines

+4 more

Side effects data

From 2021 Phase 2 trial • 112 Patients • NCT02090114

57%

fatigue

40%

Musculoskeletal pain

37%

Increased Hemoglobin

23%

Hypertension

23%

nausea

17%

Anemia

17%

Breast Tenderness

17%

rash

17%

hot flashes

17%

cough

13%

weight loss

13%

gynecomastia

13%

pruritis

13%

edema

13%

dizziness

10%

constipation

10%

Creatinine Increased

10%

anorexia

10%

abdominal pain

10%

fall

10%

sinusitis

10%

headache

10%

High cholesterol

10%

eye discorder

Syncope

chest pain

cold symptoms

diarrhea

myocardial infarction

insomnia

Acute Renal Insufficiency

anxiety

Elevated liver enzymes

Elevated hematocrit

Pancreatitis, elevated lipase, amylase

gallstone

fever

Taster change

Elevated potassium

Shortness of breath

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A:Post-enzalutamide

Cohort B: Post-abiraterone

Cohort C: Castration Only

Cohort D: Mutation

COMBAT-CRPC Trial Design

1Treatment groups

Experimental Treatment

Group I: Bipolar Androgen Therapy + NivolumabExperimental Treatment2 Interventions

All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Testosterone cypionate

2014

Completed Phase 2

~440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

559 Previous Clinical Trials

32,954 Total Patients Enrolled

57 Trials studying Prostate Cancer

3,383 Patients Enrolled for Prostate Cancer

Bristol-Myers SquibbIndustry Sponsor

2,642 Previous Clinical Trials

4,130,078 Total Patients Enrolled

41 Trials studying Prostate Cancer

5,402 Patients Enrolled for Prostate Cancer

Mark Markowski, MD, Ph.DPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there negative health effects associated with Testosterone cypionate usage?

"While there is some evidence to support the safety of Testosterone cypionate, as this is only a Phase 2 trial, there is no data currently suggesting that it is an effective medication."

Answered by AI

Are there any volunteer openings for this clinical trial right now?

"Recruitment for this study has closed. It was originally posted on September 5th, 2018 but was last updated on October 24th, 2022. However, there are 1377 other trials recruiting patients with prostate cancer and 778 studies actively enrolling participants who are taking Testosterone cypionate."

Answered by AI

Is there precedent for Testosterone cypionate research?

"Testosterone cypionate was first studied in the year 2004 at USC/Norris Comprehensive Cancer Center and Hospital. So far there are a total of 440 completed clinical trials. There are currently 778 active trials, with a large number of these studies concentrated in San Francisco, California."

Answered by AI

How many individuals are involved in this clinical trial?

"Currently, this clinical trial is not in the process of recruiting patients. The study was first posted on September 5th, 2018 and has undergone its most recent edit on October 24th, 2022. If you are seeking other medical studies, there are 1377 trials for prostate cancer and 778 trials for Testosterone cypionate that are actively looking for participants."

Answered by AI

What are some common conditions that testosterone cypionate is used to address?

"Testosterone cypionate is often used to treat melanoma that cannot be surgically removed. In addition, it can help patients with a high risk of cancer recurrence or those suffering from squamous cell carcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

COMbination of Bipolar Androgen Therapy and Nivolumab

2018. "COMbination of Bipolar Androgen Therapy and Nivolumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03554317.