APX005M in Patients With Recurrent Ovarian Cancer

NCT05201001 | Withdrawn Phase 2 DMC

• 1 other identifier: ENGOT-OV64/NSGO-CTU-SOLERO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective is to demonstrate preliminary efficacy of APX005M-carboplatin-PLD and APX005M-radiotherapy-carboplatin-PLD combinations as treatment for relapsed BRCAwt ovarian cancer patients, where platinum combination therapy is an option.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate according to RECIST at 12 weeks of treatment

  To evaluate the preliminary efficacy of APX005M-carboplatin-PLD and APX005M radiotherapycarboplatin-PLD combinations

  18 months

Secondary Outcomes (1)

• Adverse events

  18 months

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

Carboplatin AUC = 5, IV day 1 and pegylated liposomal doxorubicin (PLD) 30 mg/m , IV day1 q4 wks Total:6 cycles or until progressive disease or unacceptable toxicity.

Drug: APX005M

APX005M

EXPERIMENTAL

Carboplatin AUC = 5, IV day 1 combined with pegylated liposomal doxorubicin (PLD) 30 mg/m , IV day1 q4 wks APX005M 0.3 mg/kg, days 1 \& 15 IV q4 wks x concomitant with chemotherapy Total:6 cycles or until progressive disease or unacceptable toxicity.

Drug: APX005M

APX005M+RT

EXPERIMENTAL

Carboplatin AUC = 5, IV day 1 combined with pegylated liposomal doxorubicin (PLD) 30 mg/m , IV day1 q4 wks APX005M 0.3 mg/kg, days 1 \& 15 IV q4 wks x concomitant with chemotherapy External beam radiation therapy; a dose of 0.5 Gy per fraction, administered as single fractions prior to APX005M administration; days 1 \& 15 q4 wks x 6 cycles. Maximum 24 wks of therapy; total dose 6 Gy. Total:6 cycles or until progressive disease or unacceptable toxicity.

Drug: APX005M

Interventions

APX005M DRUG

adding immunotherapy with or without radiation therapy to chemotherapy. Low dose radiation therapy is to sensitise tumour cells to immunotherapy.

Also known as: Radiation therapy, carboplatin and PLD

APX005M; APX005M+RT; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation.
• Histologically diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer.
• Radiological or histological confirmation of relapse disease ≥ 6 month after last chemotherapy
• Known BRCAwt
• Have completed at least one line of platinum-containing chemotherapy (maximum three previous lines of therapy are permitted). Earlier PARPi treatment permitted
• Must have measurable or evaluable disease according to RESIST 1.1.
• Baseline biopsy: Tissue biopsy for submission to central laboratory prior to study treatment should be from a newly obtained metastatic biopsy, if there is a lesion suitable for biopsy. If a metastatic biopsy is not feasible, or patient is unwilling to provide new biopsy, archival tissue samples should be submitted. Archival tissue sample from metastatic site is preferred; however, archival tissue sample of primary tumor is acceptable.
• Must consent to undergo mandatory tumor biopsy of at least one metastatic site at baseline and at day 84 ( 7). Biopsy at day 84 ( 7) is only applicable if surgery is not performed. -

You may not qualify if:

• Previous immunotherapy (for example anti-PD-1/L1).
• Other malignancy unless curatively treated with no evidence of disease for ≥ 3years, except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) and stage 1 grade 1 endometrial carcinoma.
• Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \>500 ms, electrolyte disturbances, etc.), or subjects with congenital long QT syndrome.
• Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML. Page 48 af 128 ENGOT-OV64/NSGO-CTU-SOLERO EudraCT: 2020-005990-29 Final Version 1.0, 06. July 2021
• Subjects with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Subjects with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Subjects who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) or physiologic replacement doses (i.e. prednisone 5 - 7.5 mg/day) for adrenal insufficiency may be enrolled in the study. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Prior radiation therapy.
• Planned concomitant therapy with any other anticancer therapy
• Conditions requiring ongoing therapy with antibiotics
• History of any arterial thromboembolic event within 3 months prior to first dose of APX005M
• Active coagulopathy
• Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation
• History of organ transplant
• Major surgery or significant traumatic injury within 4 weeks prior to first dose of study drugs
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: lead
• Belgian Gynaecological Oncology Group: collaborator
• GSO Global Clinical Research BV: collaborator
• The Central and Eastern European Gynecologic Oncology Group: collaborator
• Swiss GO Trial Group: collaborator

Study Sites (1)

NSGO-CTU

Copenhagen, Region Sjælland, 2100, Denmark

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

sotigalimab; Radiotherapy; Carboplatin; 1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals

Study Officials

• Mansoor R Mirza

  NSGO-CTU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised, open-label, three arm study

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: January 21, 2022
• Study Start: September 7, 2023
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: September 11, 2023

Record last verified: 2022-04

Locations

DK (1)