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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol Myers Squibb International Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Feb 2023 → 11 Sep 2025

Decision date (initial)

2024-04-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-504111-33-00

EudraCT number

2021-004807-42

WHO UTN

U1111-1269-0669

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

1. To compare objective response rate of MORAb-202 vs Investigator's Choice (IC) chemotherapy (in all randomized participants)
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 participants

Secondary objectives 4

1. 1. To assess the safety and tolerability of MORAb-202 and IC chemotherapy in all treated participants
2. 2. To evaluate disease control rate (DCR) of MORAb-202 and IC chemotherapy in all randomized participants
3. 3. To evaluate Duration of Response (DoR) of MORAb-202 and IC chemotherapy in all randomized participants
4. 4. To evaluate Progression-Free Survival (PFS) of MORAb-202 and IC chemotherapy in all randomized participants

Conditions and MedDRA coding

Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1) Participants must be 18 years old or local age of majority at the time of signing the informed consent
2. 2) Female participants with histologically confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
3. 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. 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. 5) Disease progression per RECIST v1.1 (by Investigator assessment) of at least 1 measurable lesion on or after the most recent therapy.
6. 6) Either formalin-fixed, paraffin-embedded (FFPE) tissue or newly obtained biopsies must be available for FRα assessment prior to randomization.
7. 7) Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Exclusion criteria 14

1. Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer
2. Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
3. Clinically significant pericardial effusion requiring drainage
4. Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months before treatment.
5. Recent chest radiotherapy received under 6 months before starting study treatment
6. Any autoimmune, connective tissue, or inflammatory disorders where there is documented (or suspicion of) pulmonary involvement
7. Uncontrolled or significant cardiovascular conditions within 6 months prior
8. 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
9. Prior treatment with an investigational FRα-targeting agent and FRα-targeting ADC
10. 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
11. Inadequate liver function evidenced by abnormal levels of total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or serum albumin
12. Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients
13. History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C
14. Participants currently in other interventional trials may not participate in BMS clinical trials until the protocol specific washout period is achieved

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment
2. 2. Occurence of TRAEs leading to discontinuation.

Secondary endpoints 3

1. 1. Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading to discontinuation, AESIs, deaths and laboratory abnormalities
2. 2. DoR by RECIST v1.1 per investigator Assessment among responders
3. 3. PFS by RECIST v1.1 per Investigator Assessment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol Myers Squibb International Corporation

Sponsor organisation

Bristol Myers Squibb International Corporation

Address

Terhulpsesteenweg 185

City

Watermaal-Bosvoorde

Postcode

1170

Country

Belgium

Scientific contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT Representative

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT Representative

Third parties 7

Locations

3 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications