drugset / Trial / NCT06072781
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
Phase 3
Recruiting
270 enrolled
Verastem, Inc.
Australia New Zealand Gynaecological Oncology Group · collabEuropean Network of Gynaecological Oncological Trial Groups (ENGOT) · collabGOG Foundation · collabKorean Gynecologic Oncology Group · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
Timeline
- Start
- 2024-03-18
- Primary completion
- 2028-10-15
- Completion
- 2031-02-09
Publications
- Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, Prendergast E, Oaknin A, Ring K, Colombo N, Holloway RW, Rodrigues M, Chon HS, Gourley C, Santin AD, Thaker PH, Gennigens C, Newman G, Salinas E, Youssoufian H, Moore KN, Lustgarten S, O'Malley DM, Van Gorp T, Grisham RN. The combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer: a plain language summary of the Phase II clinical trial ENGOT-OV60/GOG-3052/RAMP 201. Future Oncol. 2025 Dec;21(30):3859-3871. doi: 10.1080/14796694.2025.2595130. Epub 2025 Dec 12.
- Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, Prendergast E, Oaknin A, Ring K, Colombo N, Holloway RW, Rodrigues M, Chon HS, Gourley C, Santin AD, Thaker PH, Gennigens C, Newman G, Salinas E, Youssoufian H, Moore KN, Lustgarten S, O'Malley DM, Van Gorp T, Grisham RN. Efficacy and Safety of Avutometinib +/- Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201. J Clin Oncol. 2025 Sep;43(25):2782-2792. doi: 10.1200/JCO-25-00112. Epub 2025 Jul 11.
- Grisham R, Monk BJ, Van Nieuwenhuysen E, Moore KN, Fabbro M, O'Malley DM, Oaknin A, Thaker P, Oza AM, Colombo N, Gershenson D, Aghajanian CA, Choi CH, Lee YC, Mirza MR, Coleman RL, Cobb L, Harter P, Lustgarten S, Youssoufian H, Banerjee S. GOG-3097/ENGOT-ov81/GTG-UK/RAMP 301: a phase 3, randomized trial evaluating avutometinib plus defactinib compared with investigator's choice of treatment in patients with recurrent low grade serous ovarian cancer. Int J Gynecol Cancer. 2025 Nov;35(11):101832. doi: 10.1136/ijgc-2024-005919. Epub 2025 Apr 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | 1 mg | Oral |
| Subject | Avutometinib | Small molecule | 3.2 mg | Oral |
| Subject | Defactinib | Small molecule | 200 mg | Oral |
| Comparator | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Comparator | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |