Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma (NCT05112601)
A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients With Deficient Mismatch Repair System Recurrent Endometrial Carcinoma
๐ฉบ Plain-English Summary (8th-Grade Level)
This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center โ Birmingham, Alabama
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (138 Sites)
Showing the first 25 of 138 sites.
- University of Alabama at Birmingham Cancer Center โ Birmingham, Alabama
- University Cancer and Blood Center LLC โ Athens, Georgia
- Augusta University Medical Center โ Augusta, Georgia
- Saint Alphonsus Cancer Care Center-Boise โ Boise, Idaho
- Saint Luke's Cancer Institute - Boise โ Boise, Idaho
- Saint Alphonsus Cancer Care Center-Caldwell โ Caldwell, Idaho
- Kootenai Health - Coeur d'Alene โ Coeur d'Alene, Idaho
- Saint Luke's Cancer Institute - Fruitland โ Fruitland, Idaho
- Saint Luke's Cancer Institute - Meridian โ Meridian, Idaho
- Saint Alphonsus Cancer Care Center-Nampa โ Nampa, Idaho
- Saint Luke's Cancer Institute - Nampa โ Nampa, Idaho
- Kootenai Clinic Cancer Services - Post Falls โ Post Falls, Idaho
- Kootenai Clinic Cancer Services - Sandpoint โ Sandpoint, Idaho
- University of Illinois โ Chicago, Illinois
- Carle at The Riverfront โ Danville, Illinois
- Carle Physician Group-Effingham โ Effingham, Illinois
- Carle Physician Group-Mattoon/Charleston โ Mattoon, Illinois
- Carle BroMenn Medical Center โ Normal, Illinois
- Carle Cancer Institute Normal โ Normal, Illinois
- Carle Cancer Center โ Urbana, Illinois
- IU Health North Hospital โ Carmel, Indiana
- Northwest Cancer Center - Crown Point โ Crown Point, Indiana
- Northwest Oncology LLC โ Dyer, Indiana
- Northwest Cancer Center - Hobart โ Hobart, Indiana
- Saint Mary Medical Center โ Hobart, Indiana
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Endometrial Adenocarcinoma
- Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer โ Phoenix, Arizona
- Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone โ Birmingham, Alabama
- Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment โ Basking Ridge, New Jersey
- A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma โ Mobile, Alabama
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.