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DART/SWOG/NCI phase II anti-CTLA-4/PD-1 trial: clear cell carcinomas of ovary, endometrium, cervix

Young Kwang Chae1, Megan Othus2, Sandip P Patel3

  • 1Northwestern University, Chicago, Illinois, USA chaelabmeeting@gmail.com patel@ucsd.edu rkurzrock@mcw.edu.

Journal for Immunotherapy of Cancer
|February 11, 2026
PubMed
Abstract

Insights

Dual immunotherapy with ipilimumab and nivolumab showed durable antitumor activity in gynecologic clear cell carcinomas (CCCs). Ovarian CCC patients experienced notable responses, suggesting potential for this combination therapy in rare, aggressive cancers.

Area of Science:

  • Oncology
  • Immunotherapy
  • Gynecologic Cancers

Background:

  • Dual anti-CTLA-4/PD-1 inhibitors are effective in various cancers.
  • Gynecologic clear cell carcinomas (CCCs) are rare and aggressive.
  • This study is the first to evaluate ipilimumab-nivolumab in a dedicated gynecologic CCC cohort.

Purpose of the Study:

  • To assess the efficacy of ipilimumab plus nivolumab in patients with gynecologic CCC.
  • To determine the overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).
  • To evaluate the safety and toxicity profile of the combination therapy.

Main Methods:

  • A multicenter, phase II trial (DART) involving 32 patients with gynecologic CCC.
  • Patients received ipilimumab (1 mg/kg IV q6w) plus nivolumab (240 mg IV q2w).
  • Primary endpoint was RECIST-based ORR; secondary endpoints included iRECIST ORR, PFS, OS, clinical benefit rate (CBR), and toxicity.

Main Results:

  • An overall ORR of 9.38% was observed, with two complete responses (CRs) and one partial response (PR) in ovarian CCC.
  • ORR increased to 12.5% with iRECIST, including a durable PR in cervical CCC.
  • The clinical benefit rate (CBR) was 21.88%, with a median OS of 21.7 months for all patients.

Conclusions:

  • Ipilimumab plus nivolumab demonstrated durable antitumor activity in select gynecologic CCC patients, particularly those with ovarian origin.
  • The safety profile is consistent with known ipilimumab and nivolumab toxicity.
  • Ongoing correlative studies aim to identify predictive biomarkers for treatment response.
Keywords:
Combination therapyImmune Checkpoint InhibitorOvarian CancerSolid tumor

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