NRG-GY025
Open to Accrual
Protocol Information
Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants
A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients with Deficient Mismatch Repair System Recurrent Endometrial Carcinoma
Principal Investigator
Status
Open to Accrual
Open to Accrual
February 7, 2022
Temporarily Closed to Accrual
August 5, 2024
Open to Accrual
September 12, 2024
Temporarily Closed to Accrual
August 8, 2025
Open to Accrual
September 3, 2025
Disease Site
Gynecologic [GY] Uterine Corpus
Phase
II
Developmental Therapeutics
No
Primary Objective
To assess efficacy in terms of progression-free survival
(PFS) for immunotherapy with dual immune checkpoint blockade
(nivolumab/ipilimumab) vs. monotherapy (nivolumab) in patients with recurrent
MMR deficient endometrial carcinoma with measurable or non-measurable
(detectable) disease.
Patient Population
Measurable or non-measurable (detectable) recurrent
endometrial cancer with deficient mismatch repair system
Target Accrual
90
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
Study Memos
Safety Reports
- Nivolumab-AE-2387700-Protocol-E4412-FU-2.pdf
- Ipilimumab-Nivolumab-AE-2101848-Protocol-A031704-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2812676-Protocol-EA6134-ISR.pdf
- Nivolumab-and-Ipilimumab-AE-2656714-Protocol-EA6141-FU1.pdf
- Nivolumab-AE-2937629-Protocol-10208.pdf
- Ipilimumab-Nivolumab-and-XL184-AE-2764709-Protocol-A031704-FU1.pdf
- Nivolumab-AE-2600198-Protocol-S1826-ISR.pdf
- Nivolumab-AE-2594900-Protocol-EA2165-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2337769-Protocol-A031704-ISR.pdf
- Nivolumab-AE-2606703-Protocol-NRG-HN005-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2427414-Protocol-NRG-BN007-ISR.pdf
- Nivolumab-AE-2736950-Protocol-9673-ISR.pdf
- Copanlisib-dihydrochloride-and-Nivolumab-AE-2410214-Protocol-10193-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2884258-Protocol-EA6141-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2884258-Protocol-EA6141-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2724667-Protocol-A031704-ISR.pdf
- Nivolumab-AE-2808782-Protocol-EA8143-ISR.pdf
- Nivolumab-AE-2808782-Protocol-EA8143-ISR-1.pdf
- Nivolumab-AE-2387700-Protocol-e4412-FU3.pdf
- Nivolumab-and-XL184-AE-2299279-Protocol-A031704-FU-1.pdf
- Ipilimumab-Nivolumab-XL184-AE-2528098-Protocol-10240-FU-1.pdf
- Nivolumab-AE-2121446-Protocol-A031704-ISR.pdf
- Nivolumab-and-Ipilimumab-AE-2162782-Protocol-EA6141-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2001839-Protocol-EA2174-ISR.pdf
- Nivolumab-and-XL184-Cabozantinib-AE-2431301-Protocol-A031704-FU-2.pdf
- Nivolumab-AE-2785548-Protocol-S1826-ISR.pdf
- Nivolumab-and-Talimogene-laherparepvec-AE-2149339-Protocol-10057-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2733334-Protocol-EA6141-ISR.pdf
- Nivolumab-and-Ipilimumab-AE-2217814-and-AE-2240757-Protocol-A031704-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2858701-Protocol-A031704-ISR.pdf
- Ipilimumab-Nivolumab-and-XL184-AE-2741861-Protocol-A031702-FU-1.pdf
- Nivolumab-and-Ipilimumab-AE-2537691-Protocol-A031704-ISR.pdf
- Nivolumab-and-Talimogene-laherparepvec-AE-2149339-Protocol-10057-FU-2.pdf
- Duvelisib-and-Nivolumab-AE-2768376-Protocol-10347-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2386542-Protocol-A031704-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2000196-Protocol-EA6141-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2000196-Protocol-EA6141-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2225591-Protocol-A031704-ISR.pdf
- Axitinib-and-Nivolumab-AE-2850686-Protocol-AREN1721-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2474947-Protocol-A031702-ISR.pdf
- 1-Ipilimumab-Nivolumab-and-XL184-AE-2884721-Protocol-A031704-FU-2.pdf
- 1-Ipilimumab-Nivolumab-and-XL184-AE-2864407-Protocol-A031704-FU-1.pdf
- 1-Ipilimumab-Nivolumab-and-XL184-AE-2884721-Protocol-A031704-FU-1.pdf
- 1-Nivolumab-AE-2255992-Protocol-S1826-ISR.pdf
- Nivolumab-AE-2255992-Protocol-S1826-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2970751-Protocol-EA2201-ISR.pdf
- I-Ipilimumab-Nivolumab-AE-2970751-Protocol-EA2201-FU-1.pdf
- I-Ipilimumab-Nivolumab-and-XL184-AE-2121179-Protocol-A031704-ISR.pdf
- I-Nivolumab-AE-2255992-Protocol-S1826-FU-2.pdf
- I-Nivolumab-AE-2562894-Protocol-AREN1721-ISR.pdf
- I-Ipilimumab-Nivolumab-AE-2636208-Protocol-A031704-ISR.pdf
- AE-2758261-Protocol-A031704-ISR.pdf
- Ipi-Nivo-AE-2781391-Protocol-A031704-FU-1.pdf
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.
-
Share this study.
-
-
-
-
