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

There are no approved treatments specifically for low grade serous ovarian cancer; current standard of care treatment options are limited in efficacy and tolerability. The combination of avutometinib with defactinib has demonstrated efficacy and a consistent safety profile in two clinical trials in...

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Veröffentlicht in:International journal of gynecological cancer Jg. 35; H. 11; S. 101832
Hauptverfasser: Grisham, Rachel, Monk, Bradley J, Van Nieuwenhuysen, Els, Moore, Kathleen Nadine, Fabbro, Michel, O'Malley, David M, Oaknin, Ana, Thaker, Premal, Oza, Amit M, Colombo, Nicoletta, Gershenson, David, Aghajanian, Carol A, Choi, Chel Hun, Lee, Yeh Chen, Mirza, Mansoor Raza, Coleman, Robert L, Cobb, Lauren, Harter, Philipp, Lustgarten, Stephanie, Youssoufian, Hagop, Banerjee, Susana
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States Elsevier Limited 01.11.2025
Schlagworte:
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cancer therapies
Chemotherapy
Clinical trials
Clinical Trials, Phase III as Topic
Cystadenocarcinoma, Serous - drug therapy
Cystadenocarcinoma, Serous - pathology
Disease control
FDA approval
Female
Humans
Kinases
Laboratories
Neoplasm Recurrence, Local - drug therapy
Neoplasm Recurrence, Local - pathology
Ovarian cancer
Ovarian Neoplasms - drug therapy
Ovarian Neoplasms - pathology
Patients
Phosphorylation
Randomized Controlled Trials as Topic
Response rates
Standard of care
Toxicity
United Kingdom > UK
clinical trial
FAK
Low grade serous ovarian cancer
MEK
defactinib
RAS
RAF
avutometinib
LGSOC
ISSN:1048-891X, 1525-1438, 1525-1438
Online-Zugang:Volltext
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Zusammenfassung:There are no approved treatments specifically for low grade serous ovarian cancer; current standard of care treatment options are limited in efficacy and tolerability. The combination of avutometinib with defactinib has demonstrated efficacy and a consistent safety profile in two clinical trials in recurrent low grade serous ovarian cancer, and a lower discontinuation rate due to adverse events compared with historical rates for standard of care. To compare the progression-free survival of the combination of avutometinib with defactinib versus investigator's choice of treatment in patients with recurrent low grade serous ovarian cancer. Combination treatment with avutometinib-defactinib will significantly improve progression-free survival compared with investigator's choice of treatment in patients with recurrent low grade serous ovarian cancer. GOG-3097/ENGOT-ov81/GTG-UK/RAMP 301 is a phase 3, randomized, international, open-label study designed to compare avutometinib with defactinib versus investigator's choice of treatment in patients with recurrent low grade serous ovarian cancer who have progressed on a previous platinum-based therapy. On confirmation of disease progression using a blinded independent central review, patients on the investigator's choice of treatment arm may cross over to the avutometinib-defactinib arm. Patients must have recurrent low grade serous ovarian cancer (KRAS mutant or wild-type) and have documented progression (radiographic or clinical) or recurrence of low grade serous ovarian cancer after at least one platinum-based chemotherapy regimen. Unlimited additional previous lines of therapy are allowed, including previous MEK/RAF inhibitor. Patients will be excluded if they have co-existing high grade ovarian cancer or had previous treatment with avutometinib, defactinib, or any other FAK inhibitor. Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, blinded-independent central review. Approximately 270 patients will be randomized in a 1:1 fashion to either the combination avutometinib with defactinib arm (n∼135) or the investigator's choice of treatment arm (n∼135). The estimated primary completion date of RAMP 301 is 2028, and the estimated study completion date is 2031. ClinicalTrials.gov NCT06072781.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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ISSN:1048-891X
1525-1438
1525-1438
DOI:10.1136/ijgc-2024-005919