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Compares treatment options for Ovarian Neoplasms
Official title A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)
ClinicalTrials.gov ID: NCT07286266
What this study is testing
What is Mocertatug rezetecan?
Mocertatug rezetecan is an investigational medicine, being studied as a potential treatment for ovarian neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments. The study also assesses whether Mo-Rez is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of the drug.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed...
- Has epithelial ovarian cancer, inclusive of primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade...
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, must have had a response...
- Participants who have received \>1 line of platinum therapy must have progressed on or ≤6 months after the date of the last dose of platinum therapy.
- Has received at least 1 but no more than 4 prior lines of systemic anti-cancer therapy. Prior lines of therapy are defined as follows:
You likely can't join if
- Has primary platinum-refractory Ovarian Cancer (OC), defined as disease that did not respond to or has progressed within \<3 months of the final dose...
- Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization...
- Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor...
- Has untreated brain or CNS metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new...
- Has any evidence of current ILD or pneumonitis, or a prior history of ILD or non-infectious pneumonitis.
- Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy...
See the full eligibility criteria
Who can join
- Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF).
- Has epithelial ovarian cancer, inclusive of primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, or clear cell carcinoma, or carcinosarcoma...
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, must have had a response (CR, PR, stable disease) and then progressed from \>3 months to ≤6...
- Participants who have received \>1 line of platinum therapy must have progressed on or ≤6 months after the date of the last dose of platinum therapy.
- Has received at least 1 but no more than 4 prior lines of systemic anti-cancer therapy. Prior lines of therapy are defined as follows:
- Adjuvant ± neoadjuvant are considered one line of therapy.
- Maintenance therapy (e.g., bevacizumab, [poly adenosine diphosphate-ribosylation (ADP) ribose polymerase inhibitor (PARPi)] will be considered as part of the preceding line of therapy (i.e., not counted independently).
- Therapy changed to another agent in the same class due to toxicity in the absence of progression will be considered as part of the same line of therapy (i.e., not counted independently).
- Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy.
- Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance.
- Must have received prior treatment with the following therapies unless they have a contraindication per label or institutional guidelines as described below:
- Mirvetuximab soravtansine (MIRV),.
- The tumor demonstrates positive folate receptor alpha FRα expression (≥ 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining) per a test compliant to local regulation, AND
- Does not have a documented contraindication per label or local institutional guidelines, including but not limited to chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring...
- It is available in the enrolment country. A regimen is considered available if it is approved and reimbursed (covered by national healthcare or private insurance) in the participating country.
- Bevacizumab, unless the participant has a documented contraindication per label or local institutional guidelines. Contraindications include but are not limited to vascular disorders (uncontrolled hypertension, arterial...
- PARPi, in participants with known or suspected deleterious germline or somatic BRCA mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose...
- Has at least one Target lesion (TL) per RECIST 1.1, as determined by the investigator. Measurable lesions that have been previously irradiated and have been shown to be progressing following irradiation may be...
- Has provided a Formalin fixed, paraffin embedded (FFPE) tumor tissue sample of sufficient quantity and quality for the central assessment of B7 homolog 4 protein (B7-H4) expression, with B7-H4 expression result...
- FR alpha expression
- In countries where mirvetuximab is available, an FR alpha expression result from a test compliant with local regulation or by central testing is required to determine eligibility.
- In countries where mirvetuximab is unavailable, an FFPE tumor tissue sample confirmed to be of sufficient quantity and quality must be provided. The FR alpha expression result is not required prior to randomisation or...
- PD-L1 expression, where a result from a local test is NOT available, an FFPE tumor tissue sample confirmed to be of sufficient quantity and quality must be provided. The PD-L1 expression result is not required prior to...
- Is eligible to receive 1 of the standard of care interventions if assigned by chance to physician's choice arm.
- A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
- Is a Participant of non-childbearing potential (PONCBP) OR
- Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, 30 days prior to Cycle 1 Day 1 (C1D1) and...
- A POCBP must have a negative, highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention
- If a urine test is positive or ambiguous and cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is...
- Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the study protocol.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has adequate organ function
What rules you out
- Has primary platinum-refractory Ovarian Cancer (OC), defined as disease that did not respond to or has progressed within \<3 months of the final dose of first line platinum containing chemotherapy.
- Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization, except for basal cell or squamous cell carcinomas of the skin, in-situ...
- Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- Has untreated brain or CNS metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases). Participants with...
- Has any evidence of current ILD or pneumonitis, or a prior history of ILD or non-infectious pneumonitis.
- Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, excluding e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed...
- Has any serious and/or unstable medical condition (including infection) or any serious and/or unstable psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with...
- For participants selected to receive the pembrolizumab-containing regimen as the intended physician's choice only: Has experienced any of the following with prior immunotherapy-any immune-mediated adverse event (imAE) ≥...
- For participants selected to receive bevacizumab as part of the pembrolizumab + paclitaxel ± bevacizumab intended physician's choice regimen only: Has a history of vascular disorders (uncontrolled hypertension, arterial...
- Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1.
- Has received treatment with an investigational agent within 30 days prior to date of C1D1.
- Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy, or investigational agent) within 30 days or 5...
- Has ever received prior therapy with topoisomerase I inhibitors (e.g., topotecan) or ADC with a topo1i payload, or B7-H4 targeted therapy.
- Has received any live vaccine within 30 days prior to date of C1D1.
- Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony stimulating factor (G-CSF), granulocyte macrophage...
- For participants receiving PLD only: Has baseline Left ventricular ejection fraction (LVEF) \<50% or lower than institutional lower limits of normal. Intolerance to PLD does not exclude a participant from the study if a...
The study team makes the final eligibility decision.
Where it's taking place
- Randwick, New South Wales, Australia
- Montreal, Quebec, Canada
- Hyōgo, Japan
- Osaka, Japan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Randwick, New South Wales, Australia; Montreal, Quebec, Canada; Hyōgo, Japan; Osaka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.