Cetrelimab for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma+11 More
Cetrelimab - Biological
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is studying 3 chemotherapy drugs given together, followed by a PARP inhibitor with or without an immunotherapy drug, to see if it can help control aggressive variant prostate cancer.

Eligible Conditions
  • Carcinoma
  • Malignant Neoplasms
  • Carcinoma, Neuroendocrine
  • Castration-Resistant Prostate Carcinoma
  • Carcinoma, Small Cell
  • Malignant neoplasm of prostate
  • Aggressive Variant Prostate Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival (OS)
Year 5
Progression-free survival
Day 30
Incidence of adverse events
Up to 5 years
Response rate
Response rate by circulating tumor cells

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Group II (cetrelimab, niraparib)
1 of 2
Group I (niraparib)
1 of 2
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Cetrelimab · No Placebo Group · Phase 2

Group II (cetrelimab, niraparib)Experimental Group · 4 Interventions: Carboplatin, Cetrelimab, Cabazitaxel, Niraparib · Intervention Types: Drug, Biological, Drug, Drug
Group I (niraparib)Experimental Group · 4 Interventions: Carboplatin, Cetrelimab, Cabazitaxel, Niraparib · Intervention Types: Drug, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Cabazitaxel
FDA approved
Niraparib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,643 Total Patients Enrolled
258 Trials studying Carcinoma
36,161 Patients Enrolled for Carcinoma
Janssen PharmaceuticaIndustry Sponsor
36 Previous Clinical Trials
7,961 Total Patients Enrolled
Ana AparicioPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
301 Total Patients Enrolled
2 Trials studying Carcinoma
276 Patients Enrolled for Carcinoma

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The text is discussing metastatic disease, which is documented on imaging studies such as bone scans, CT scans, and MRIs.
Plain x-rays and CT scans can identify predominately lytic bone metastases.
Tumor masses in the prostate or pelvis that are larger than 5 cm in their longest dimension and show signs of aggressive growth are referred to as bulky lymphadenopathy or high-grade tumor mass.
greatly facilitates the conduct of an ethical study and is often required by study sponsors
before their specimens are used for tumor profiling and treatment recommendation
You have histologically proven small cell (neuroendocrine) prostate carcinoma.
You have a histologically or cytologically confirmed prostate carcinoma.
You have low PSA (< 10 ng/mL) at initial presentation (prior to androgen ablation or at symptomatic progression in the castrate-setting) plus high volume (>= 20) bone metastases.
You must agree to tissue collection for correlative studies at the specified timepoints.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
M D Anderson Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%