Ovarian NeoplasmsPhase 3NCT07694427
Mo-Rez in First- Line (1L) Maintenance Treatment of Non-Homologous Recombination Deficient Ovarian Cancer (Non-HRd OC) [BEHOLD-Ovarian03]
A Phase 3 study testing Mocertatug rezetecan and Bevacizumab in people with Ovarian Neoplasms, run by GlaxoSmithKline at 12 sites in 5 countries.
Trial summary
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) alone or in combination with bevacizumab works in treating ovarian cancer compared to bevacizumab alone or active observation (AO). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Mocertatug rezetecan and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 2 Oct 2026to 8 Nov 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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, clear cell carcinoma, carcinosarcoma or mixed histology.
- 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 (HIPEC) regimens are acceptable. In the event of history of platinum or paclitaxel allergy, alternative agents are allowed (in consultation with the sponsor). At least cycles of first-line chemotherapy must be completed with or without bevacizumab.
- 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 evidence of disease (NED), or Stable disease (SD).
- Is able to commence C1D1 of study treatment within 9 weeks of the final dose of front-line therapy. Final dose of front-line therapy is defined as the last day that platinum-based chemotherapy with/without bevacizumab was given. Participants may continue bevacizumab dosing if specified cycles of bevacizumab post-chemotherapy are administered prior to randomization.
Show all 20Show fewer
- 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. Fine needle aspirates, bone marrow samples, bone specimens, or cell blocks are not acceptable. Additional details regarding acceptable biopsy collections and processing can be found in the Laboratory Manual and other laboratory documentation. Tumor sample may also be used for other biomarker testing.
- 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.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 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), preferably with low user dependency, as described in Protocol, 30 days prior to C1D1 and during the study intervention period and for at least 8 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.
- 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. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- 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.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- 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 in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.
- 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.
Show all 48Show fewer
- 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 metastases). Participants with previously treated and clinically stable brain/CNS metastases and who have completed all corticosteroid therapy for ≥14 days prior to the date of C1D1 are not excluded from participation.
- 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 replacement therapy, Grade 2 neuropathy, or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.
- 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 the participant's safety, obtainment of informed consent, or compliance to the study procedures.
- 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; participants with GI fistula, visceral fistula, or abdominal abscess within 6 months prior to the date of C1D1; has osteonecrosis of the jaw.
- 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 participation) other than maintenance bevacizumab. Cytotoxic chemotherapy drugs or other antitumor drugs include endocrine therapy, molecular targeted therapy, immunotherapy, or biotherapy.
- 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 treatment with inducers of P-gp within 14 days prior to 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 colony-stimulating factor (GM-CSF), or recombinant Erythropoietin (EPO)s) within 14 days prior to date of C1D1.
- Has a known Human immunodeficiency virus (HIV) infection AND meets at least 1 of the following criteria:
- Has documented evidence of plasma HIV-1 Ribonucleic acid (RNA) ≥50 c/mL within 3 months prior to or at screening. In the 3 months to 12 months prior to screening, plasma HIV-1 RNA levels consistently <50 c/mL are required for enrollment; if multiple instances of plasma HIV-1 RNA values ≥50 c/mL occurred in the 3 months to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR
- 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 with locally recommended guidelines during the 3 months prior to screening; OR
- 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 disease [CDC, 2014] are eligible (provided all other applicable criteria are met) if the Acquired immunodeficiency syndrome (AIDS)-defining disease has been treated and cured or is stable for at least 3 months prior to screening. Cutaneous Kaposi's Sarcoma not requiring systemic therapy is not exclusionary.
- 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 criteria.
- 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 jaundice. Participants who exhibit these signs or symptoms as a result of the malignancy under investigation and whose conditions are deemed adequately controlled by the investigator may be eligible for inclusion. Stable noncirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones), hepatobiliary involvement of malignancy, or chronic stable Hepatitis B virus (HBV) infection (in a participant for whom Hepatitis D virus (HDV) infection has been excluded) or chronic Hepatitis C virus (HCV) infection is acceptable if the participant otherwise meets entry criteria.
- Has documented positive Hepatitis B surface antigen (HBsAg) at screening, unless they meet all of the following criteria:
- 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 to continue for at least 6 months after the last dose of study intervention or longer at the discretion of the treating hepatologist;
- Have undetectable HBV DNA, per institutional or local guidelines, at screening;
- Have documented negative HDV antibody testing at screening.
- Has documented positive Hepatitis B surface antibody (HBcAb) at screening unless they meet all of the following criteria:
- 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. The HCV RNA test is optional, and participants with a negative HCV antibody test are not required to undergo HCV RNA testing as well. Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled if a confirmatory negative HCV RNA test is obtained and the participant otherwise meets entry criteria.
- 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 arrhythmia not controlled by standard of care therapy.
- 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; or adjustment of antihypertensive medications due to poor blood pressure control within 14 days prior to the C1D1.
- 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. Only participants with ≥2+ proteinuria on dipstick at screening will undergo a 24-hour urine collection. Participants with ≥2+ proteinuria on dipstick but <1g of protein in 24 hours are eligible.
Trial locations and contacts
12 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 5 countries
Argentina5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Buenos Aires, C1017 AAS
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
CABA, C1187
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, C1414DRK
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, C1426AGE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Viedma, R8500ACE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Canada2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Montreal, Quebec, H4A 3J1
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toronto, Ontario, M5G 1Z5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Japan2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Niigata, 951-8520
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Osaka, 569-8686
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Korea2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Seoul, Seoul Teugbyeolsi, 06351
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, Seoul Teugbyeolsi, 3080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Kogarah, New South Wales, 2217
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan With or Without Bevacizumab in Comparison to Active Observation With or Without Bevacizumab as Maintenance Treatment in Participants With Newly Diagnosed FIGO Stage III/IV Non-Homologous Recombination Deficient Ovarian Cancer
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) alone or in combination with bevacizumab works in treating ovarian cancer compared to bevacizumab alone or active observation (AO). The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to bevacizumab alone OR AO and will help provide a better understanding of the main side effects of the drugs.
- Conditions
- Ovarian Neoplasms
- Being tested
- Mocertatug rezetecan, Bevacizumab
- Keywords
- Ovarian Cancer, Mocertatug rezetecan, Mo-Rez, GSK5733584, Bevacizumab, Active Observation, BEHOLD-Ovarian03
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mocertatug rezetecanDrug
Mocertatug rezetecan will be administered
BevacizumabDrug
Bevacizumab will be administered
| Study group | Role | What they receive |
|---|---|---|
| Mocertatug rezetecan +/- Bevacizumab | Experimental | Not described Receives: Drug: Mocertatug rezetecan; Drug: Bevacizumab |
| Active Observation +/- Bevacizumab | Active comparator | Not described Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first
Measured: Up to approximately 34 months
Secondary outcomes (15)
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
Measured: Up to approximately 72 months
PFS by investigator assessment
PFS is defined as the time from the date of randomization to the date of first documented Progressive disease (PD) per RECIST 1.1 by investigator or death from any cause, whichever occurs first
Measured: Up to approximately 72 months
Time to first subsequent therapy (TFST)
TFST is defined as the time from the date of randomization to the date of initiation of subsequent therapy or death from any cause, whichever occurs first
Measured: Up to approximately 72 months
Time to second subsequent therapy (TSST)
TSST is defined as the time from the date of randomization to the date of initiation of second subsequent therapy or death from any cause, whichever occurs first
Measured: Up to approximately 72 months
Time from randomization to objective progression on first subsequent anticancer therapy or death from any cause (PFS2)
PFS2 is defined as the time from the date of randomization to the date of first documented investigator-assessed clinical or radiographical progression following the first subsequent anticancer therapy and after the progression event used for PFS, or death from any cause, whichever is earlier.
Measured: Up to approximately 72 months
Number of participants with Treatment-emergent adverse event (TEAEs), Adverse event of special interest (AESIs) and Treatment-emergent serious adverse event (TESAEs)
Measured: Up to approximately 72 months
Number of participants with TEAEs leading to dose modifications or study intervention discontinuation
Measured: Up to approximately 72 months
Number of participants with changes in vital signs, laboratory tests and Electrocardiogram (ECG)
Number of participants will be assessed
Measured: Up to approximately 72 months
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
The EORTC QLQ-C30 includes 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of ovarian cancer participants. These include functional scales, symptom scales, global health status scale, and single item scales. Scores are averaged and transformed to 0 to 100. Higher scores indicate greater functioning, better global health status, or more severe symptoms
Measured: Up to approximately 72 months
Change from baseline in EORTC QLQ-Ovarian Cancer Module (OV28) score
The EORTC QLQ-OV28 includes a 28-item questionnaire for evaluating ovarian cancer-specific symptoms and concerns in participants of cancer clinical studies. These include items that assess symptoms in the abdominal/gastrointestinal domain. Scores are averaged and transformed to a 0 to 100 scale; higher scores indicate a greater symptom burden, while lower scores reflect fewer symptoms.
Measured: Up to approximately 72 months
Time to deterioration (TTD) of EORTC QLQ-C30
TTD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on any of the following EORTC QLQ-C30 domains: physical functioning, role functioning and Global Health Status (GHS)/ Quality of Life (QoL).
Measured: Up to approximately 72 months
TTD of EORTC QLQ-OV28
TTD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal/gastrointestinal symptom domain of the EORTC QLQ-OV28
Measured: Up to approximately 72 months
Pharmacokinetic (PK) concentration of Mocertatug rezetecan
Measured: Up to approximately 72 months
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Mocertatug rezetecan
Measured: Up to approximately 72 months
Titers of ADA against Mocertatug rezetecan
Measured: Up to approximately 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start2 Oct 2026
- Primary completion6 Sep 2029 (estimated)
- Study completion8 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ENGOT, GOG, APGOT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694427
- Sponsor's protocol ID
- 224037
- Other IDs
- 2025-523365-13-00, ENGOT-ov105, GOG-3135, APGOT-OV20, 2025
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan With or Without Bevacizumab in Comparison to Active Observation With or Without Bevacizumab as Maintenance Treatment in Participants With Newly Diagnosed FIGO Stage III/IV Non-Homologous Recombination Deficient Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07694427
- Acronym / sponsor ID
- 224037
- Conditions
- Ovarian Neoplasms
- Keywords
- Ovarian Cancer, Mocertatug rezetecan, Mo-Rez, GSK5733584, Bevacizumab, Active Observation, BEHOLD-Ovarian03
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- ENGOT, GOG, APGOT
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- 6 Sep 2029 (estimated)
- Study completion
- 8 Nov 2032 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) alone or in combination with bevacizumab works in treating ovarian cancer compared to bevacizumab alone or active observation (AO). The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to bevacizumab alone OR AO and will help provide a better understanding of the main side effects of the drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mocertatug rezetecan +/- Bevacizumab | Experimental | Drug: Mocertatug rezetecan, Drug: Bevacizumab |
| Active Observation +/- Bevacizumab | Active comparator | Drug: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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, clear cell carcinoma, carcinosarcoma or mixed histology.
- 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 (HIPEC) regimens are acceptable. In the event of history of platinum or paclitaxel allergy, alternative agents are allowed (in consultation with the sponsor). At least cycles of first-line chemotherapy must be completed with or without bevacizumab.
- 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 evidence of disease (NED), or Stable disease (SD).
Key exclusion criteria (48 listed)
- 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 in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mocertatug rezetecanMocertatug rezetecan will be administered | Drug | Mocertatug rezetecan +/- Bevacizumab |
| BevacizumabBevacizumab will be administered | Drug | Active Observation +/- Bevacizumab, Mocertatug rezetecan +/- Bevacizumab |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to approximately 34 months
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first
15 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 72 months
PFS by investigator assessment
Time frame: Up to approximately 72 months
Time to first subsequent therapy (TFST)
Time frame: Up to approximately 72 months
Time to second subsequent therapy (TSST)
Time frame: Up to approximately 72 months
Time from randomization to objective progression on first subsequent anticancer therapy or death from any cause (PFS2)
Time frame: Up to approximately 72 months
Number of participants with Treatment-emergent adverse event (TEAEs), Adverse event of special interest (AESIs) and Treatment-emergent serious adverse event (TESAEs)
Time frame: Up to approximately 72 months
Number of participants with TEAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 72 months
Number of participants with changes in vital signs, laboratory tests and Electrocardiogram (ECG)
Time frame: Up to approximately 72 months
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
Time frame: Up to approximately 72 months
Change from baseline in EORTC QLQ-Ovarian Cancer Module (OV28) score
Time frame: Up to approximately 72 months
Time to deterioration (TTD) of EORTC QLQ-C30
Time frame: Up to approximately 72 months
TTD of EORTC QLQ-OV28
Time frame: Up to approximately 72 months
Pharmacokinetic (PK) concentration of Mocertatug rezetecan
Time frame: Up to approximately 72 months
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Mocertatug rezetecan
Time frame: Up to approximately 72 months
Titers of ADA against Mocertatug rezetecan
Time frame: Up to approximately 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Related trials for Ovarian Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mocertatug rezetecan and Bevacizumab in people with Ovarian Neoplasms, run by GlaxoSmithKline at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Argentina, Canada, Japan, South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to approximately 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.