Ovarian Neoplasms study: Mocertatug rezetecan vs Bevacizumab
Official title Mo-Rez in First- Line (1L) Maintenance Treatment of Non-Homologous Recombination Deficient Ovarian Cancer (Non-HRd OC) [BEHOLD-Ovarian03]
ClinicalTrials.gov ID: NCT07694427
What this study is testing
What is Mocertatug rezetecan?
An investigational medicine being studied for the treatment of ovarian cancer.
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 is testing whether Mo-Rez alone or with bevacizumab works better than bevacizumab alone or no treatment. It also looks at how safe Mo-Rez is and what side effects it causes.
- Who it's for
- You may be able to join if you have ovarian cancer that does not have a certain DNA repair problem.
- What's involved
- You would take Mo-Rez by mouth, sometimes with bevacizumab, and you would have regular doctor visits and tests to check how you are doing.
- Time commitment
- The study lasts about 12 months and includes several clinic visits and blood tests.
- Phase 3: a large, late-stage study
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 newly diagnosed Stage III/IV (2014 FIGO staging) [Berek, 2021] epithelial ovarian, primary peritoneal or fallopian tube cancer with a...
- Has completed first-line platinum-based chemotherapy cycles. Inclusion of IV regimens at Q3W cycles, consolidation regimens and Intravenous (IV)/...
- Has Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) response determined by investigator after the completion of first-line...
- Is able to commence C1D1 of study treatment within 9 weeks of the final dose of front-line therapy.
You likely can't join if
- Has Ovarian cancer (OC) with germline or somatic pathogenic/likely pathogenic Breast cancer gene (BRCA)1/2 mutation or evidence of homologous repair...
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to date of...
- First-line Poly adenosine diphosphate-ribosylation (ADP) ribose polymerase inhibitor(s) (PARPi) for maintenance is a treatment option for...
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- 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 Central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain...
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 newly diagnosed Stage III/IV (2014 FIGO staging) [Berek, 2021] epithelial ovarian, primary peritoneal or fallopian tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid...
- Has completed first-line platinum-based chemotherapy cycles. Inclusion of IV regimens at Q3W cycles, consolidation regimens and Intravenous (IV)/ Intraperitoneal (IP) and Hyperthermic intraperitoneal chemotherapy...
- Has Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) response determined by investigator after the completion of first-line treatment must be Complete response (CR), Partial response (PR), No...
- Is able to commence C1D1 of study treatment within 9 weeks of the final dose of front-line therapy.
- If planning to receive bevacizumab: Has received at least specified number of cycles of bevacizumab per label and local approval in combination front-line chemotherapy
- Has provided a sample sufficient for Homologous repair deficiency (HRD) testing (if local testing is not available), and the results available prior to date of randomization.
- Tumor specimen should be obtained from the most recent procedure and from a site not previously irradiated. If a suitable archival sample is not available, a fresh tumor tissue sample must be obtained during Screening.
- Is willing to use adequate contraception. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- 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), preferably with low user dependency, as described in Protocol, 30 days...
- 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 cannot be confirmed as negative (e.g., a positive result or an indeterminate result), a serum pregnancy test is required.
- Additional requirements for pregnancy testing during and after study intervention are provided in Protocol
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy.
- Is capable of giving signed informed consent as described, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.
- Has adequate organ function.
What rules you out
- Has Ovarian cancer (OC) with germline or somatic pathogenic/likely pathogenic Breast cancer gene (BRCA)1/2 mutation or evidence of homologous repair deficiency as per local or central test.
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or...
- First-line Poly adenosine diphosphate-ribosylation (ADP) ribose polymerase inhibitor(s) (PARPi) for maintenance is a treatment option for participants, as determined by the Principal Investigator.
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- 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 Central nervous system (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...
- Has any evidence of current Interstitial lung disease (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 alopecia, hearing loss, vitiligo, endocrinopathy managed with...
- 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...
- Has clinically significant wound healing complications or incompletely healed wounds.
- Has a history or evidence of Gastrointestinal (GI) perforation, tracheoesophageal fistula, or any Grade 4 fistula
- Has evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on Computed tomography (CT) scan or clinical symptoms of bowel obstruction.
- Has clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 30 days prior to the date of C1D1.
- Has congenital bleeding diathesis, acquired coagulopathy, recent pulmonary hemorrhage/hemoptysis (\>2.5 mL of red blood or a half teaspoon) within the last 3 months prior to the date of C1D1.
- 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 any cytotoxic chemotherapy drugs or other antitumor drugs within 30 days or 5 half-lives, whichever is shorter, prior to date of C1D1 (or need to continue these drugs during study...
- Has received treatment with an investigational agent within 30 days of the date of C1D1.
- Has ever received prior therapy with ADC or B7-H4 targeted therapy.
- Has received treatment with inhibitors of P-glycoprotein (P-gp), Breast cancer gene (BCRP), or Organic anion transporting polypeptides (OATP) 1B1/1B3 transporters within 7 days prior to the date of C1D1.
- Has received any live vaccine within 30 days of C1D1. mRNA and adenoviral based Coronavirus disease 2019 (COVID-19) vaccines are considered non-live.
- Has received any transfusion of blood products (including platelets or RBCs) or administration of colony-stimulating factors (including Granulocyte colony stimulating factor (G-CSF), Granulocyte macrophage...
- Has documented evidence of plasma HIV-1 Ribonucleic acid (RNA) ≥50 c/mL within 3 months prior to or at screening.
- Has not had Cluster of differentiation (CD)4 cell counts measured in the past 12 months (i.e., at least 2 separate measurements taken a minimum of 28 days apart, 1 of which must be conducted at screening); OR
- Has had any CD4 cell count values ≤350 cells/mm3 in the past 12 months; OR
- Has had 1 or more changes in their combination antiretroviral therapy regimen (except for switches as allowed per details provided in the protocol) or has received an antiretroviral therapy regimen that is inconsistent...
- Has a history of HIV-associated non-Hodgkin lymphoma within 5 years prior to screening; OR
- Has received treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening. Participants with history of Centers for Disease Control and Prevention (CDC) Stage III disease (also known as AIDS defining...
- Has an Alanine aminotransferase (ALT) value \>2.5 × Upper limit of normal (ULN) and/or, for participants with documented liver metastases/tumor infiltration, has an ALT value \>5 × ULN.
- Has a total bilirubin value \>1.5 × ULN. Participants with Gilbert's syndrome can be included with a total bilirubin value \>1.5 × ULN, provided direct bilirubin is ≤1.5 × ULN and participant otherwise meets entry...
- Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent...
- Are receiving effective antiviral therapy (i.e., with nucleos(t)ide analogs with a high barrier to viral resistance [tenofovir or entecavir]) for at least 7 days prior to first dose of study intervention and are willing...
- Have undetectable HBV DNA, per institutional or local guidelines, at screening;
- Have documented negative HDV antibody testing at screening.
- Have undetectable HBV DNA, per institutional or local guidelines, at screening;
- Have negative HBsAg at screening.
- Has a positive HCV antibody test result at screening unless HCV RNA is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment.
- Has QTcF \>470 msec.
- Has a history within 12 months prior to screening of clinically significant or uncontrolled cardiac disease, acute MI, New York Heart Association Class III or IV congestive heart failure ], or clinically significant...
- Has baseline Left ventricular ejection fraction (LVEF) \<50% or less than institutional Lower limit of normal (LLN)
- Has clinically significant abnormal BP according to investigator assessment, or inadequately treated and uncontrolled hypertension including history of hypertensive crisis; hypertensive encephalopathy
- Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety). Successfully managed renal obstruction is permitted.
- Has a history of nephrotic syndrome or Grade 3 proteinuria.
- Meets the following criteria for proteinuria during screening assessments: ≥2+ proteinuria on urine dipstick and 24-hour urine collection demonstrating ≥1g of urine in 24 hours.
The study team makes the final eligibility decision.
Where it is enrolling
- Buenos Aires, Argentina
- CABA, Argentina
- Ciudad Autonoma de Buenos Aire, Argentina
- Viedma, Argentina
- Kogarah, New South Wales, Australia
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Niigata, Japan
- Osaka, Japan
- Seoul, Seoul Teugbyeolsi, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Buenos Aires, Argentina; CABA, Argentina; Ciudad Autonoma de Buenos Aire, Argentina; Viedma, Argentina; Kogarah, New South Wales, Australia; Toronto, Ontario, Canada and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.