Ovarian Cancer
Conditions
Keywords
Ovarian Cancer, Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Rinatabart Sesutecan, Rina-S, Antibody-drug Conjugate, Maintenance Treatment, Bevacizumab, Folate Receptor Alpha
Brief summary
This Phase 3 study will be conducted in different countries around the world with up to approximately 602 participants. The purpose of this study is to evaluate how well Rina-S alone or in combination with an approved, standard of care (SOC) treatment works against ovarian cancer (including primary peritoneal or fallopian tube cancer) compared to the same available SOC therapy by itself, or no treatment (only monitoring). On average, the expected trial duration for an individual participant will be approximately 4 years (depending on treatment received). The treatment length and follow-up duration will be different for every participant, but an average of 16 months of treatment is expected, followed by an estimated 29-month post treatment follow up period. Participation in the study will require visits to the study site(s). Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the trial treatment is safe and effective. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep receiving trial treatment for the protocol-defined study duration.
Detailed description
This is a global, randomized, open-label, Phase 3 study of Rina-S + SOC (defined as either bevacizumab maintenance or no maintenance treatment \[observation\]) versus SOC as maintenance treatment in participants with newly diagnosed high-grade epithelial ovarian cancer who are not considered to be a candidate for poly (ADP-ribose) polymerase (PARP) inhibitor(s) (PARPi) maintenance therapy according to local SOC.
Interventions
DRUGRina-S
Intravenous (IV) infusion.
DRUGBevacizumab
IV infusion.
Sponsors
Genmab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III, or IV high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube carcinoma. * Participants must have received 6 cycles of 1L-platinum-based chemotherapy, in accordance with applicable clinical guidelines. Up to 8 cycles are permitted based on local clinical practice. * Participants not deemed candidates for surgery or who have completed planned cytoreductive surgery (either primary debulking surgery \[PDS\] or IDS) are eligible. * Participants must meet one of the following criteria after completion of 1L platinum-based chemotherapy: * Participants who received platinum-based chemotherapy with bevacizumab must have achieved complete response (CR)/no clinical evidence of disease (NED), partial response (PR), or stable disease (SD), as assessed by the investigator, and be eligible to continue bevacizumab maintenance. * Participants who received platinum-based chemotherapy without bevacizumab must have achieved CR/NED or PR, as assessed by the investigator, and be considered appropriate for observation. * Trial intervention must start within 3 to 12 weeks of the last dose of front-line chemotherapy. To avoid a treatment-free interval, bevacizumab administration should continue following the final platinum dose, provided the participant remains eligible through screening and up to the point of randomization, and no contraindications exist. Key
Exclusion criteria
* Participant has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors. * Participant has received any intervening systemic anticancer treatment excluding bevacizumab or a biosimilar administered as part of 1L treatment after the last dose of 1L platinum-based chemotherapy and before randomization. * Participant with any previous treatment with PARPi. * Participants with previous therapy with other anti-angiogenic agents different from bevacizumab or biosimilar. * Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase 1 inhibitor. * Participant has received prior therapy with ADC targeting folate receptor alpha (FRα). Note: Other protocol-defined Inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS), per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, as Determined by Blinded Independent Central Review (BICR) | Approximately 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Approximately 4 years |
| PFS per RECIST v1.1, as Determined by Investigator Assessment | Approximately 4 years |
| Progression-free Survival on the Next Line of Therapy after the First Progression (PFS2) | Approximately 4 years |
| Time to First Subsequent Therapy (TFST) | Approximately 4 years |
| Time to Second Subsequent Therapy (TSST) | Approximately 4 years |
| Number of Participants with Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria | Approximately 4 years |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) Including Serious Adverse Events (SAEs) and Deaths | Approximately 4 years |
| Overall Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Questionnaire | Baseline up to approximately 4 years |
| Time to Deterioration (TTD) in the GHS/QoL Score using the EORTC QLQ C30 Questionnaire | Baseline up to approximately 4 years |
Contacts
CONTACTGenmab Trial Information
STUDY_DIRECTORStudy Official
Genmab
Outcome results
None listed