Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

Trial Title: Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

NCT ID: NCT06619236

Condition: Platinum-resistant Ovarian Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Paclitaxel
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Topotecan

Conditions: Keywords:
antibody-drug conjugate
folate receptor alpha (FRα)
ovarian cancer
fallopian tube cancer
primary peritoneal cancer
folate receptor
platinum-resistant ovarian cancer (PROC)
rinatabart sesutecan
Topoisomerase 1 inhibitor
PRO1184
GEN1184

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Rina-S
Description: IV infusion
Arm group label: Rina-S

Other name: PRO1184

Other name: Rinatabart Sesutecan

Other name: GEN1184

Intervention type: Drug
Intervention name: Paclitaxel
Description: IV infusion
Arm group label: Investigator's Choice

Intervention type: Drug
Intervention name: Topotecan
Description: IV infusion
Arm group label: Investigator's Choice

Intervention type: Drug
Intervention name: Pegylated liposomal doxorubicin (PLD)
Description: IV infusion
Arm group label: Investigator's Choice

Intervention type: Drug
Intervention name: Gemcitabine
Description: IV infusion
Arm group label: Investigator's Choice

Summary: This phase 3 study will be conducted in different countries all over the world with about 530 participants. The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. The study duration is anticipated to be up to 3 years. All participants will receive active drug; no one will be given placebo.

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: - Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. - Participants must have received platinum-based therapy. - Participants must have received prior treatment with the following therapies: - Platinum chemotherapy - Bevacizumab, unless contraindication is documented - Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor - Mirvetuximab soravtansine, if: - Mirvetuximab soravtansine is available in the enrollment region, and - The participant is eligible based on positive FRα expression per Food and Drug Administration (FDA)-approved (or local equivalent) test, and - The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision. - Participants must have platinum-resistant disease: - Participants who have only had platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of platinum-based therapy, and then progressed after the date of the last dose of platinum. - Participants who have received platinum-based therapy must have progressed after the date of the last dose of platinum. Key Exclusion Criteria: - Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor. - Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed after the last dose of a first-line platinum-containing regimen. - History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer. - Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry. - Hospitalization or clinical symptoms due to gastrointestinal obstruction or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility. - Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management. Enrollment of participants with an indwelling peritoneal catheter must be discussed with the medical monitor to determine eligibility. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: December 15, 2024

Completion date: November 30, 2029

Lead sponsor:
Agency: Genmab
Agency class: Industry

Source: Genmab

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06619236