A Phase 2, Randomised, Open Label, Multicentre Study of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery

Oncoinvent Solutions AS10 sites in 6 countries114 target enrollmentJune 15, 2024

ConditionsPeritoneal Carcinomatosis Ovarian Cancer

InterventionsRadspherin

DrugsRadspherin

Overview

Phase: Phase 2
Intervention: Radspherin
Conditions: Peritoneal Carcinomatosis
Sponsor: Oncoinvent Solutions AS
Enrollment: 114
Locations: 10
Primary Endpoint: Progression free survival
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.

Registry

clinicaltrials.gov

Start Date

June 15, 2024

End Date

February 28, 2031

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Oncoinvent Solutions AS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP).
•Female of age ≥ 18 years.
•Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB/C or IV).
•Peritoneal and other metastases eligible for IDS to no residual tumour.
•Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy.
•Confirmed HR proficient by Myriad MyChoice CDx testing.
•Received NACT (numbers of cycles as per investigator's discretion) with regress or stable disease on diagnostic imaging and assessed to be operable to R0 pre-surgery.
•Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 2 and patient fit enough to undergo IDS and further treatment according to standard of care.
•Adequate renal function:
•Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml/min or measured creatinine clearance ≥ 40 ml/min.

Exclusion Criteria

•Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.
•Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images.
•Epithelial borderline tumours, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumours, non-epithelial ovarian malignancies, carcinosarcoma and neuroendocrine tumours or recurrent ovarian cancer.
•Symptomatic central nervous system metastasis.
•Another primary malignancy within the past 3 years (except for non melanoma skin cancer, cutaneous melanoma stage 1, cervical cancer in situ or FIGO 2023 Stage IA1 or IA3 prior or synchronous endometrial cancer).
•Prior abdominal/pelvic radiotherapy.
•Disease progression during NACT.
•Pregnant or lactating (nursing) women.
•Active infections requiring antibiotics, and/or physician monitoring, or recurrent fever \> 38.0⁰C associated with a clinical diagnosis of active infection.
•Active liver disease with positive serology for active hepatitis B, hepatitis C or known human immunodeficiency virus (HIV).

Arms & Interventions

Radspherin

Intervention: Radspherin

Control

Outcomes

Primary Outcomes

Progression free survival

Time Frame: 24 months

To compare PFS in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer1 with peritoneal metastasis that are HR proficient following Radspherin® treatment versus no treatment.