RECRUITING

A Study of Radspherin® in Patients with Primary Advanced Epithelial Cancer, with Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery

Conditions

Peritoneal Carcinomatosis Ovarian Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-15

Study Completion:2031-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06504147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP). 2. Female of age ≥ 18 years. 3. 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). 4. Peritoneal and other metastases eligible for IDS to no residual tumour. 5. Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy. 6. Confirmed HR proficient by Myriad MyChoice CDx testing. 7. Completed 3 or 4 cycles of NACT with regress or stable disease on diagnostic imaging and assessed to be operable to R0. 8. 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. 9. Adequate renal function: 10. Adequate hepatic function: * Serum bilirubin \< 1.5 x upper limit of normal (ULN), and * Aspartate transaminase and alanine transaminase ≤ 3 x ULN. 11. Adequate bone marrow function: * Absolute neutrophil count ≥ 1.0 x 10\^9/l, and * Platelets ≥ 100 x 10\^9/l, and * Haemoglobin ≥ 9 g/dL. 12. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment. 13. For females of childbearing potential agreement to use at least one of the following highly effective (failure rate \< 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®, unless hysterectomy or oophorectomy is performed during IDS. * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. * Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.	1. Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient. 2. Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images. 3. 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. 4. Symptomatic central nervous system metastasis. 5. 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). 6. Prior abdominal/pelvic radiotherapy. 7. Disease progression during 3 to 4 cycles of NACT. 8. Pregnant or lactating (nursing) women. 9. Active infections requiring antibiotics, and/or physician monitoring, or recurrent fever \> 38.0⁰C associated with a clinical diagnosis of active infection. 10. Active liver disease with positive serology for active hepatitis B, hepatitis C or known human immunodeficiency virus (HIV). 11. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease. 12. Any condition or illness that, in the opinion of the investigator or the medical monitor, would compromise the safety of the patients or interfere with the evaluation of the safety of the investigational medicinal product. 13. In the investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent. 14. Administration of an investigational medicinal product within 4 weeks, or at least 5 times the half life, prior to enrolment. 15. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the surgery. 16. Treatment with bevacizumab within 5 weeks prior to IDS. 17. Known hypersensitivity to any of the excipients of the study drug.

Inclusion Criteria

Exclusion Criteria

1. Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP).
2. Female of age ≥ 18 years.
3. 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).
4. Peritoneal and other metastases eligible for IDS to no residual tumour.
5. Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy.
6. Confirmed HR proficient by Myriad MyChoice CDx testing.
7. Completed 3 or 4 cycles of NACT with regress or stable disease on diagnostic imaging and assessed to be operable to R0.
8. 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.
9. Adequate renal function:
10. Adequate hepatic function:
* Serum bilirubin \< 1.5 x upper limit of normal (ULN), and
* Aspartate transaminase and alanine transaminase ≤ 3 x ULN.
11. Adequate bone marrow function:
* Absolute neutrophil count ≥ 1.0 x 10\^9/l, and
* Platelets ≥ 100 x 10\^9/l, and
* Haemoglobin ≥ 9 g/dL.
12. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.
13. For females of childbearing potential agreement to use at least one of the following highly effective (failure rate \< 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®, unless hysterectomy or oophorectomy is performed during IDS.
* Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
* Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
* Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

1. Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.
2. Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images.
3. 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.
4. Symptomatic central nervous system metastasis.
5. 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).
6. Prior abdominal/pelvic radiotherapy.
7. Disease progression during 3 to 4 cycles of NACT.
8. Pregnant or lactating (nursing) women.
9. Active infections requiring antibiotics, and/or physician monitoring, or recurrent fever \> 38.0⁰C associated with a clinical diagnosis of active infection.
10. Active liver disease with positive serology for active hepatitis B, hepatitis C or known human immunodeficiency virus (HIV).
11. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease.
12. Any condition or illness that, in the opinion of the investigator or the medical monitor, would compromise the safety of the patients or interfere with the evaluation of the safety of the investigational medicinal product.
13. In the investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent.
14. Administration of an investigational medicinal product within 4 weeks, or at least 5 times the half life, prior to enrolment.
15. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the surgery.
16. Treatment with bevacizumab within 5 weeks prior to IDS.
17. Known hypersensitivity to any of the excipients of the study drug.

Contacts and Locations

Study Contact

Anne-Kirsti Aksnes, PhD

CONTACT

004722183305

aksnes@oncoinvent.com

Trine Jensen Gjertsen

CONTACT

004722183305

gjertsen@oncoinvent.com

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: Oncoinvent AS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-15

Study Completion Date2031-02-28

Study Record Updates

Study Start Date2024-06-15

Study Completion Date2031-02-28

Terms related to this study

Additional Relevant MeSH Terms

Peritoneal Carcinomatosis
Ovarian Cancer