NCT04679064: NItCHE-MITO33

Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

Status unknown Phase 3 Last updated 27 August 2021

What this trial tests

Phase 3 trial testing Niraparib in Ovarian Cancer in 427 participants. Status unknown.

Timeline

1 December 2020

Primary endpoint
1 January 2025

1 January 2025

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	427
Start date	1 December 2020
Primary completion	1 January 2025
Estimated completion	1 January 2025
Sites	8 locations across Italy

Drugs / interventions tested

• Niraparib (niraparib) — full drug profile →
• Dostarlimab
• Pegylated liposomal doxorubicin
• Paclitaxel — full drug profile →
• Gemcitabine
• Topotecan (topotecan) — full drug profile →
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option

Publications & conference data

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

1. Immune Regulatory Processes of the Tumor Microenvironment under Malignant Conditions.
   Pansy K, Uhl B, Krstic J, Szmyra M, et al · · 2021 · cited 87× · PMID 34948104 · DOI 10.3390/ijms222413311
2. Current Understanding on Why Ovarian Cancer Is Resistant to Immune Checkpoint Inhibitors.
   Pawłowska A, Rekowska A, Kuryło W, Pańczyszyn A, et al · · 2023 · cited 41× · PMID 37446039 · DOI 10.3390/ijms241310859
3. Dostarlimab: A Review.
   Costa B, Vale N. · · 2022 · cited 39× · PMID 35892341 · DOI 10.3390/biom12081031
4. Immune checkpoint blockades in gynecological cancers: A review of clinical trials.
   Peng H, He X, Wang Q. · · 2022 · cited 38× · PMID 35751489 · DOI 10.1111/aogs.14412
5. Combining PARP inhibition and immune checkpoint blockade in ovarian cancer patients: a new perspective on the horizon?
   Musacchio L, Cicala CM, Camarda F, Ghizzoni V, et al · · 2022 · cited 37× · PMID 35849879 · DOI 10.1016/j.esmoop.2022.100536
6. Chasing Immune Checkpoint Inhibitors in Ovarian Cancer: Novel Combinations and Biomarker Discovery.
   Colombo I, Karakasis K, Suku S, Oza AM. · · 2023 · cited 35× · PMID 37370830 · DOI 10.3390/cancers15123220
7. Synthetic Lethality in Ovarian Cancer.
   Chandrasekaran A, Elias KM. · · 2021 · cited 34× · PMID 34518297 · DOI 10.1158/1535-7163.mct-21-0500
8. The Interplay between PARP Inhibitors and Immunotherapy in Ovarian Cancer: The Rationale behind a New Combination Therapy.
   Maiorano BA, Lorusso D, Maiorano MFP, Ciardiello D, et al · · 2022 · cited 28× · PMID 35409229 · DOI 10.3390/ijms23073871