Can I read Phase 1/2 trial of avelumab combined with utomilumab (4‐1BB agonist), PF‐04518600 (OX40 agonist), or radiotherapy in patients with advanced gynecologic malignancies on EtoBox?

Phase 1/2 trial of avelumab combined with utomilumab (4‐1BB agonist), PF‐04518600 (OX40 agonist), or radiotherapy in patients with advanced gynecologic malignancies by Anne Knisely; Jibran Ahmed; Bettzy Stephen; Sarina A. Piha‐Paul; Daniel Karp; Abdulrazzak Zarifa; Siqing Fu; David Sanghyun Hong; Jordi Rodon Ahnert; Timothy A. Yap; Apostolia M. Tsimberidou; Anas Alshawa; Ecaterina E. Dumbrava; Yali Yang; Juhee Song; Funda Meric‐Bernstam; Amir A. Jazaeri; Aung Naing is a Medicine article available to read on EtoBox.

What is Phase 1/2 trial of avelumab combined with utomilumab (4‐1BB agonist), PF‐04518600 (OX40 agonist), or radiotherapy in patients with advanced gynecologic malignancies about?

## Abstract ## Background Immune checkpoint blockade has shown mixed results in advanced/recurrent gynecologic malignancies. Efficacy may be improved through costimulation with OX40 and 4‐1BB agonists. The authors sought to evaluate the safety and efficacy of avelumab combined with utomilumab (a 4‐1BB agonist), PF‐04518600 (an OX40 agonist), and radiotherapy in patients with recurrent gynecologic malignancies. ## Methods The primary end point in this six‐arm, phase 1/2 trial was safety of the combination regimens. Secondary end points included the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors and immune‐related Response Evaluation Criteria in Solid Tumors, the disease control rate (DCR), the duration of response, progression‐free survival, and overall survival. ## Results Forty patients were included (35% with cervical cancer, 30% with endometrial cancer, and 35% with ovarian cancer). Most patients (__n__ = 33; 83%) were enrolled in arms A–C (no radiation). Among 35 patients who were evaluable for efficacy, the ORR was 2.9%, and the DCR was 37.1%, with a median duration of stable disease of 5.4 months (interquartile range, 4.1–7.3 months).

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Author

Anne Knisely; Jibran Ahmed; Bettzy Stephen; Sarina A. Piha‐Paul; Daniel Karp; Abdulrazzak Zarifa; Siqing Fu; David Sanghyun Hong; Jordi Rodon Ahnert; Timothy A. Yap; Apostolia M. Tsimberidou; Anas Alshawa; Ecaterina E. Dumbrava; Yali Yang; Juhee Song; Funda Meric‐Bernstam; Amir A. Jazaeri; Aung Naing

Publisher

Wiley

Published

2023

Field

Medicine (Health Sciences)