| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
|
| E.1.1.1 | Medical condition in easily understood language |
| Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10033128 |
| E.1.2 | Term | Ovarian cancer |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10016180 |
| E.1.2 | Term | Fallopian tube cancer |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10052171 |
| E.1.2 | Term | Peritoneal carcinoma |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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 |
|
| E.2.2 | Secondary objectives of the trial |
1. To evaluate Disease Control Rate (DCR) of MORAb-202 and IC chemotherapy in all randomized participants
2. To evaluate Duration of Response (DoR) of MORAb-202 and IC chemotherapy in all randomized participants
3. To evaluate Progression-Free Survival (PFS) of MORAb-202 and IC chemotherapy in all randomized participants
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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 FRα assessment prior to randomization.
7) Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
|
|
| E.4 | Principal exclusion criteria |
Main 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 FRα-targeting agent and FRα-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
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment
2. Occurence of TRAEs leading to discontinuation. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to 2 years
2. Up to 2 years |
|
| E.5.2 | Secondary end point(s) |
1. Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading to discontinuation, AESIs, deaths and laboratory abnormalities
2. DoR by RECIST v1.1 per investigator Assessment among responders
3. PFS by RECIST v1.1 per Investigator Assessment
4. DCR by RECIST v1.1 per Investigator Assessment
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to 2 years
2. Up to 2 years
3. Up to 2 years
4. Up to 2 years
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 26 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Australia |
| Chile |
| Israel |
| Japan |
| Korea, Republic of |
| United States |
| Belgium |
| France |
| Italy |
| Spain |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| End of study is defined as the last participant’s last visit. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 4 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 4 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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