Combination Immunotherapy in Rare Cancers Under InvesTigation

Summary

The four tumour streams that will be studied in this protocol are based on immunotherapy sensitive rare cancers from CA209-538 which will be further investigated under this protocol and divided into four groups: 1. Neuroendocrine cancers: Atypical bronchial carcinoid, neuroendocrine carcinoma and Grade 3 NETs independent of primary site (SCLC excluded) 2. Biliary tract cancers: Intrahepatic cholangiocarcinoma and gallbladder carcinoma 3. Gynaecological malignancies: Ovarian clear cell carcinoma, uterine clear cell carcinoma, uterine/ovarian carcinosarcoma, uterine leiomyosarcoma and vaginal/vulva squamous cell carcinoma 4. Mismatch repair protein deficient (MSI-H) cancers (excluding colorectal carcinoma). The role of immunotherapy is being defined in more common cancer types, however because of their rarity, the efficacy of immunotherapy for these cancers is poorly defined. This protocol provides an important opportunity to establish whether the combination of nivolumab \& ipilimumab has efficacy in these cancers.

Timeline

Start

2021-08-03

Primary completion

2025-03-01

Completion

2027-03-01

Publications

• Carlino MS, Gao B, Michael M, Marshall H, Gunjur A, Chan H, Zielinski R, So J, Harris SJ, Kee D, Collins IM, Lam WS, Lyle M, Underhill C, Brown MP, Harrup R, Wong SF, Grady J, Ballinger M, Tavancheh E, Thomas DM, Palmer J, Wilkie K, Cebon J, Klein O. Nivolumab and Ipilimumab in Advanced Mismatch Repair-Deficient/Microsatellite Instability-High Noncolorectal Cancers: A Nonrandomized Clinical Trial. JAMA Oncol. 2026 Jan 1;12(1):39-47. doi: 10.1001/jamaoncol.2025.4721.
• Gao B, Carlino MS, Michael M, Underhill C, Marshall H, Gunjur A, So J, Kee D, Antill Y, Lam WS, Chan H, Harrup R, Hamilton A, Grady J, Ballinger M, Tavancheh E, Yoon WH, Palmer J, Thomas D, Wilkie K, Cebon J, Klein O. Nivolumab and Ipilimumab Combination Treatment in Advanced Ovarian and Endometrial Clear Cell Cancers: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):982-989. doi: 10.1001/jamaoncol.2025.1916.

Drugs

Indications