A Phase 2 Study of MORAb-202 in Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 1

Conditions: Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-004807-42-IT

Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 150

Inclusion Criteria

1) Participants must be 18 years old or local age of majority at the time of signing the informed consent
2) Female participants with histologically confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
3) Platinum-resistant disease, defined as:
- For participants who had only 1 line of platinum-based therapy: progression between > 1 month and <= 6 months after the last dose of platinum-based therapy of at least 4 cycles.
- For participants who had 2 or 3 lines of platinum-based therapy: progression <= 6 months after the last dose of platinum-based therapy.
4) Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance.
- Participants must have received prior treatment with bevacizumab or must be deemed medically inappropriate or ineligible/intolerant to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.
NOTES:
Neoadjuvant ± adjuvant chemotherapy will be considered 1 line of therapy.
Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy.
Therapy changed in the absence of progression will be considered part of the same line.
5) Disease progression per RECIST v1.1 (by Investigator assessment) of at least 1 measurable lesion on or after the most recent therapy.
6) Either formalin-fixed, paraffin-embedded (FFPE) tissue or newly-obtained biopsies must be available for FRa assessment prior to randomization.
7) Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

- Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer
- Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen.
- Pulmonary function test (PFT) abnormalities
- Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at Screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy.
- Recent chest radiotherapy received under 6 months before starting study treatment
- Any autoimmune, connective tissue, or inflammatory disorders where there is documented (or suspicion of) pulmonary involvement
- Uncontrolled or significant cardiovascular conditions within 6 months prior
- Uncontrolled medical disorders that, in the opinion of the Investigator or Sponsor, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results
- Prior treatment with an investigational FRa-targeting agent and FRa-targeting ADC
- Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- Inadequate liver function evidenced by abnormal levels of total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or serum albumin
- Has any prior severe hypersensitivity (>= Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients
- History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C
- Participants currently in other interventional trials may not participate in BMS clinical trials until the protocol specific washout period is achieved

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To compare objective response rate of MORAb-202 vs Investigator's Choice (IC) chemotherapy (in all randomized participants)<br>2. To evaluate the proportion of participants with treatment-related adverse events (TRAEs) leading to discontinuation in each arm within 6 months from first dose of study drug administration in all treated<br>participants;Secondary Objective: 1. To evaluate Disease Control Rate (DCR) of MORAb-202 and IC chemotherapy in all randomized participants<br>2. To evaluate Duration of Response (DoR) of MORAb-202 and IC chemotherapy in all randomized participants<br>3. To evaluate Progression-Free Survival (PFS) of MORAb-202 and IC chemotherapy in all randomized participants;Primary end point(s): 1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment<br>2. Occurence of TRAEs leading to discontinuation.;Timepoint(s) of evaluation of this end point: 1 and 2: up to 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading<br>to discontinuation, AESIs, deaths and laboratory abnormalities<br>2. DoR by RECIST v1.1 per investigator Assessment among responders<br>3. PFS by RECIST v1.1 per Investigator Assessment<br>4. DCR by RECIST v1.1 per Investigator Assessment;Timepoint(s) of evaluation of this end point: 1, 2, 3 and 4: up to 2 years

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