Ovarian NeoplasmsPhase 3NCT07684612
A Study to Investigate Mocertatug Rezetecan With Bevacizumab Compared With Platinum Doublet With Bevacizumab in Participants With Platinum-sensitive Ovarian Cancer (BEHOLD-Ovarian02)
A Phase 3 study testing Mocertatug rezetecan (Mo-Rez), Carboplatin and Paclitaxel in people with Ovarian Neoplasms, run by GlaxoSmithKline at 9 sites in 4 countries.
Trial summary
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) in combination with bevacizumab works in treating platinum-sensitive ovarian cancer compared to standard treatments by checking whether it makes cancers smaller or disappear completely and if it helps participants live longer. 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 (Mo-Rez), Carboplatin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 8 Sep 2026to 22 Apr 2033
- 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
- 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, primary peritoneal, or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, clear cell carcinoma, or carcinosarcoma.
- Has recurrent or progressive disease after completion of at least 1 and a maximum of 2 previous lines of systemic anticancer therapy. Recurrent or progressive disease should be determined based on radiographic assessment according to RECIST 1.1 per investigator and/or clinical assessment of disease progression by investigator. Prior lines of therapy are defined as follows:
- Adjuvant ± neoadjuvant is considered one line of therapy.
- Maintenance therapy (e.g., bevacizumab, Poly 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 (i.e., not counted independently).
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- 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.
- Has platinum-sensitive disease and is suitable for platinum doublet chemotherapy with bevacizumab for the treatment of recurrent disease. Platinum sensitive disease is defined as recurrent or progressive disease >6 months after last dose of platinum-based chemotherapy.
- Has documented results of local testing (compliant to local regulations) for tumor and/or germline Breast Cancer Gene (BRCA1 and BRCA2) mutation. Participants with a known tumor or germline deleterious BRCA1 or BRCA2 mutation must have previously received PARPi maintenance therapy, alone or in combination with bevacizumab, if the participant was considered a candidate for this treatment and the treatment is locally available.
- Has provided a Formalin Fixed Paraffin Embedded (FFPE) tumor tissue sample sufficient for the central assessment of B7 homolog 4 protein (B7-H4) expression, with the result of B7-H4 expression testing available prior to the date of randomization.
- 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 they are 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, 30 days prior to Cycle 1 Day 1 (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., noncompliance, 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.
- Is capable of giving signed informed consent including compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has adequate organ function.
Who cannot join
- Plans to undergo interval secondary cytoreductive surgery for recurrent PSOC during induction therapy (platinum doublet and bevacizumab).
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to the 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.
- 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 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.
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- 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 perforation, tracheoesophageal fistula, or any Grade 4 fistula; has gastrointestinal 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 3 months prior to the date of C1D1.
- Has had any major surgery within 28 days prior to the date of C1D1 or history of focal radiotherapy within 21 days prior to the date of C1D1.
- Has received treatment with an investigational agent within 30 days prior to the date of C1D1.
- Has ever received prior therapy with topoisomerase 1 inhibitor [Topo1i] (e.g., topotecan) or antibody-Drug Conjugate (ADC) with a Topo1i warhead, or B7-H4 targeted therapy.
- Has received treatment with any cytotoxic chemotherapy drugs or other antitumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy or biotherapy) within 30 days or 5 half-lives, whichever is shorter, prior to the date of C1D1; or need to continue these drugs during study participation.
- Has received treatment with inhibitors of P-glycoprotein (P-gp), or Breast Cancer Resistant Protein (BCRP), or Organic Anion Transporting Polypeptides 1B1/1B3 (OATP1B1/1B3) within 7 days prior to the date of C1D1. Has received treatment with inducers of P-gp within 14 days prior to the date of C1D1.
- Has received any live vaccine within 30 days prior to the 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, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to date of C1D1.
- Has a history within 12 months prior to screening of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, 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.
- Has clinically significant abnormal blood pressure 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 date of C1D1.
- 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 ≥1 g of urine protein in 24 hours.
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 4 countries
Japan3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Hokkaido, 003-0804
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
Hyōgo, 673-8558
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
Ibaraki, 305-8576
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 Korea3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Seoul, 03722
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, 135-710
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, 138-736
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
Australia1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Newcastle, New South Wales, 2298
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 Bevacizumab Compared With Platinum Doublet With Bevacizumab in Participants With Platinum-Sensitive Ovarian Cancer
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) in combination with bevacizumab works in treating platinum-sensitive ovarian cancer compared to standard treatments by checking whether it makes cancers smaller or disappear completely and if it helps participants live longer. The study also assesses whether Mo-Rez in combination with bevacizumab is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of Mo-Rez.
- Conditions
- Ovarian Neoplasms
- Being tested
- Mocertatug rezetecan (Mo-Rez), Carboplatin, Paclitaxel, Gemcitabine, Pegylated liposomal doxorubicin (PLD)
- Keywords
- Platinum-Sensitive Ovarian Cancer (PSOC), Mocertatug Rezetecan, Mo-Rez, GSK5733584, Bevacizumab, Platinum Doublet, Carboplatin, Paclitaxel, Gemcitabine, Pegylated Liposomal Doxorubicin (PLD), Antibody-Drug Conjugate, BEHOLD-Ovarian02
- 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 rezetecan (Mo-Rez)Drug
Mocertatug rezetecan will be administered
CarboplatinDrug
Carboplatin will be administered
PaclitaxelDrug
Paclitaxel will be administered
GemcitabineDrug
Gemcitabine will be administered
Pegylated liposomal doxorubicin (PLD)Drug
PLD will be administered
BevacizumabDrug
Bevacizumab will be administered
| Study group | Role | What they receive |
|---|---|---|
| Mocertatug rezetecan (Mo-Rez) + Bevacizumab | Experimental | Participants will receive Mo-Rez + bevacizumab. Receives: Drug: Mocertatug rezetecan (Mo-Rez); Drug: Bevacizumab |
| Platinum doublet + Bevacizumab | Active comparator | Participants will receive platinum doublet chemotherapy (carboplatin with paclitaxel, gemcitabine, or pegylated liposomal doxorubicin [PLD]) and bevacizumab, followed by bevacizumab maintenance therapy. Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) by BICR
PFS is defined as the time from the date of randomization to the date of first documented disease progression (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 191 weeks
Secondary outcomes (19)
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 343 weeks
PFS by investigator assessment
PFS is defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by investigator assessment or death from any cause, whichever occurs first.
Measured: Up to approximately 343 weeks
Time to Second Progression (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 the primary variable PFS, or death from any cause, whichever occurs first.
Measured: Up to approximately 343 weeks
Objective response rate (ORR) by investigator assessment
ORR is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST 1.1 by investigator assessment.
Measured: Up to approximately 343 weeks
Duration of Response (DOR) by investigator assessment
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator assessment to the date of first documented PD per RECIST 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Measured: Up to approximately 343 weeks
ORR by BICR
ORR is defined as the percentage of participants with a CR or PR per RECIST 1.1 by BICR.
Measured: Up to approximately 343 weeks
DOR by BICR
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by BICR assessment to the date of first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Measured: Up to approximately 343 weeks
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 343 weeks
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 343 weeks
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 343 weeks
Number of participants with TEAEs leading to dose modifications or study intervention discontinuation
Measured: Up to approximately 343 weeks
Number of participants with changes in vital signs, laboratory tests (hematology and clinical chemistry), and Electrocardiogram (ECG)
Measured: Up to approximately 343 weeks
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 participants participating in cancer clinical studies. The following domains will be measured: Global health status (GHS)/ Quality of Life (QoL), physical functioning, role functioning. Participants responses on these items are averaged and then transformed to scores, ranging from 0 to 100. Higher score indicates better functioning or a better . overall state of health.
Measured: Up to approximately 343 weeks
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 343 weeks
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 343 weeks
Time to deterioration (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 343 weeks
Serum concentration of Mo-Rez
Measured: Up to approximately 343 weeks
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Mo-Rez
Measured: Up to approximately 343 weeks
Titers of ADA against Mo-Rez
Measured: Up to approximately 343 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start8 Sep 2026
- Primary completion21 May 2030 (estimated)
- Study completion22 Apr 2033 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GOG, ENGOT, APGOT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684612
- Sponsor's protocol ID
- 224040
- Other IDs
- 2025-523366-24-00, GOG- 3136, ENGOT-ov99, APGOT-OV19, 2025
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 1 Oct 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 1 Oct 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 Bevacizumab Compared With Platinum Doublet With Bevacizumab in Participants With Platinum-Sensitive Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07684612
- Acronym / sponsor ID
- 224040
- Conditions
- Ovarian Neoplasms
- Keywords
- Platinum-Sensitive Ovarian Cancer (PSOC), Mocertatug Rezetecan, Mo-Rez, GSK5733584, Bevacizumab, Platinum Doublet, Carboplatin, Paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- GOG, ENGOT, APGOT
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 21 May 2030 (estimated)
- Study completion
- 22 Apr 2033 (estimated)
- First posted
- 6 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) in combination with bevacizumab works in treating platinum-sensitive ovarian cancer compared to standard treatments by checking whether it makes cancers smaller or disappear completely and if it helps participants live longer. The study also assesses whether Mo-Rez in combination with bevacizumab is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of Mo-Rez.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mocertatug rezetecan (Mo-Rez) + Bevacizumab | Experimental | Drug: Mocertatug rezetecan (Mo-Rez), Drug: BevacizumabParticipants will receive Mo-Rez + bevacizumab. |
| Platinum doublet + Bevacizumab | Active comparator | Drug: Carboplatin, Drug: Paclitaxel, Drug: Gemcitabine, Drug: Pegylated liposomal doxorubicin (PLD), Drug: BevacizumabParticipants will receive platinum doublet chemotherapy (carboplatin with paclitaxel, gemcitabine, or pegylated liposomal doxorubicin [PLD]) and bevacizumab, followed by bevacizumab maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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, primary peritoneal, or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, clear cell carcinoma, or carcinosarcoma.
- Has recurrent or progressive disease after completion of at least 1 and a maximum of 2 previous lines of systemic anticancer therapy. Recurrent or progressive disease should be determined based on radiographic assessment according to RECIST 1.1 per investigator and/or clinical assessment of disease progression by investigator. Prior lines of therapy are defined as follows:
- Has platinum-sensitive disease and is suitable for platinum doublet chemotherapy with bevacizumab for the treatment of recurrent disease. Platinum sensitive disease is defined as recurrent or progressive disease >6 months after last dose of platinum-based chemotherapy.
- Has documented results of local testing (compliant to local regulations) for tumor and/or germline Breast Cancer Gene (BRCA1 and BRCA2) mutation. Participants with a known tumor or germline deleterious BRCA1 or BRCA2 mutation must have previously received PARPi maintenance therapy, alone or in combination with bevacizumab, if the participant was considered a candidate for this treatment and the treatment is locally available.
Key exclusion criteria (24 listed)
- Plans to undergo interval secondary cytoreductive surgery for recurrent PSOC during induction therapy (platinum doublet and bevacizumab).
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to the 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.
- 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 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.
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 rezetecan (Mo-Rez)Mocertatug rezetecan will be administered | Drug | Mocertatug rezetecan (Mo-Rez) + Bevacizumab |
| CarboplatinCarboplatin will be administered | Drug | Platinum doublet + Bevacizumab |
| PaclitaxelPaclitaxel will be administered | Drug | Platinum doublet + Bevacizumab |
| GemcitabineGemcitabine will be administered | Drug | Platinum doublet + Bevacizumab |
| Pegylated liposomal doxorubicin (PLD)PLD will be administered | Drug | Platinum doublet + Bevacizumab |
| BevacizumabBevacizumab will be administered | Drug | Mocertatug rezetecan (Mo-Rez) + Bevacizumab, Platinum doublet + Bevacizumab |
Primary outcome
Progression Free Survival (PFS) by BICR
Time frame: Up to approximately 191 weeks
PFS is defined as the time from the date of randomization to the date of first documented disease progression (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.
19 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 343 weeks
PFS by investigator assessment
Time frame: Up to approximately 343 weeks
Time to Second Progression (PFS2)
Time frame: Up to approximately 343 weeks
Objective response rate (ORR) by investigator assessment
Time frame: Up to approximately 343 weeks
Duration of Response (DOR) by investigator assessment
Time frame: Up to approximately 343 weeks
ORR by BICR
Time frame: Up to approximately 343 weeks
DOR by BICR
Time frame: Up to approximately 343 weeks
Time to first subsequent therapy (TFST)
Time frame: Up to approximately 343 weeks
Time to second subsequent therapy (TSST)
Time frame: Up to approximately 343 weeks
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 343 weeks
Number of participants with TEAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 343 weeks
Number of participants with changes in vital signs, laboratory tests (hematology and clinical chemistry), and Electrocardiogram (ECG)
Time frame: Up to approximately 343 weeks
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 343 weeks
Change from baseline in EORTC QLQ-Ovarian Cancer Module (OV28) score
Time frame: Up to approximately 343 weeks
Time to deterioration (TTD) of EORTC QLQ-C30
Time frame: Up to approximately 343 weeks
Time to deterioration (TTD) of EORTC QLQ-OV28
Time frame: Up to approximately 343 weeks
Serum concentration of Mo-Rez
Time frame: Up to approximately 343 weeks
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Mo-Rez
Time frame: Up to approximately 343 weeks
Titers of ADA against Mo-Rez
Time frame: Up to approximately 343 weeks
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 1 Oct 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
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Ovarian Cancer, Fallopian Tube Cancer
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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.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mocertatug rezetecan (Mo-Rez), Carboplatin and Paclitaxel in people with Ovarian Neoplasms, run by GlaxoSmithKline at 9 sites in 4 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 19 inclusion and 24 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan, South Korea, Canada, 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) by BICR (time frame: Up to approximately 191 weeks). 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 1 Oct 2026.