NCT04592237

Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

Active, enrolled Phase 2 Last updated 23 December 2025

What this trial tests

Phase 2 trial testing Cabazitaxel in Aggressive Variant Prostate Carcinoma in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 December 2020

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	29 December 2020
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Cabazitaxel (cabazitaxel) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Cetrelimab
• Niraparib (niraparib) — full drug profile →

Conditions studied

• Aggressive Variant Prostate Carcinoma — all drugs for Aggressive Variant Prostate Carcinoma →
• Castration-Resistant Prostate Carcinoma — all drugs for Castration-Resistant Prostate Carcinoma →
• Metastatic Prostate Carcinoma — all drugs for Metastatic Prostate Carcinoma →
• Metastatic Prostate Neuroendocrine Carcinoma — all drugs for Metastatic Prostate Neuroendocrine Carcinoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, male only, with Aggressive Variant Prostate Carcinoma or Castration-Resistant Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies the effect of cabazitaxel, carboplatin, and cetrelimab followed by niraparib with or without cetrelimab in treating patients with aggressive variant prostate cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cabazitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as cetrelimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib with or without cetrelimab, after treatment with cabazitaxel, carboplatin, and cetrelimab, may help control aggressive variant prostate cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Aggressive variants of prostate cancer: underlying mechanisms of neuroendocrine transdifferentiation.
   Merkens L, Sailer V, Lessel D, Janzen E, et al · · 2022 · cited 91× · PMID 35109899 · DOI 10.1186/s13046-022-02255-y
2. Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
   Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
3. PARP inhibitors in metastatic prostate cancer.
   Taylor AK, Kosoff D, Emamekhoo H, Lang JM, et al · · 2023 · cited 50× · PMID 37168382 · DOI 10.3389/fonc.2023.1159557
4. Clinical considerations for the management of androgen indifferent prostate cancer.
   Berchuck JE, Viscuse PV, Beltran H, Aparicio A. · · 2021 · cited 46× · PMID 33568748 · DOI 10.1038/s41391-021-00332-5
5. Lineage plasticity and treatment resistance in prostate cancer: the intersection of genetics, epigenetics, and evolution.
   Imamura J, Ganguly S, Muskara A, Liao RS, et al · · 2023 · cited 34× · PMID 37455903 · DOI 10.3389/fendo.2023.1191311
6. Exploring anti-androgen therapies in hormone dependent prostate cancer and new therapeutic routes for castration resistant prostate cancer.
   Harris AE, Metzler VM, Lothion-Roy J, Varun D, et al · · 2022 · cited 30× · PMID 36263323 · DOI 10.3389/fendo.2022.1006101
7. Expanding Therapeutic Opportunities for Extrapulmonary Neuroendocrine Carcinoma.
   Frizziero M, Kilgour E, Simpson KL, Rothwell DG, et al · · 2022 · cited 30× · PMID 35091446 · DOI 10.1158/1078-0432.ccr-21-3058
8. Advances in Treatment of Recurrent Small Cell Lung Cancer (SCLC): Insights for Optimizing Patient Outcomes from an Expert Roundtable Discussion.
   Das M, Padda SK, Weiss J, Owonikoko TK. · · 2021 · cited 30× · PMID 34564806 · DOI 10.1007/s12325-021-01909-1