Benmelstobart in Combination With Anlotinib and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial OvariaN, Fallopian Tube, or Primary Peritoneal Cancer

NCT07489300 — Phase 2, Not yet recruiting, 40 participants, Second Affiliated Hospital, Zhejiang University, School of Medicine

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Registry	NCT07489300, acronym BACON
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	Second Affiliated Hospital, Zhejiang University, School of Medicine (Other)
Conditions	Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer
Interventions	Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide (Drug)
Dates	start 2026-03-30 (estimated), primary completion 2027-01-31 (estimated), completion 2028-01-31 (estimated), first posted 2026-03-24, last updated 2026-03-24

-Summary

Efficacy and safety of Benmelstobart combined with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (BACON study) in China

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+Arms and interventions

Arm	Type	Interventions	Description
Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide	Other	Drug: Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide	Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial OvariaN, fallopian tube, or primary peritoneal cancer

Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide (Drug): Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial OvariaN, fallopian tube, or primary peritoneal cancer

+Outcome measures

Primary outcomes

progression-free survival (PFS) [from enrollment to the end of treatment at 2 years]: 24 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.

Secondary outcomes

CRR [6 months]: The objective response rate is evaluated simultaneously by using the RECIST1.1 criteria (Response Evaluation Criteria for solid Tumors) and the immune-related Response Criteria (irRECIST).
OS [5 years]: OS is defined as the time from the date of randomization until death
AEs [12 months]: Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 1.The age on the day of signing the informed consent form is 18 years or older. 2.Eastern Cooperative Oncology Group performance status of 0-1, with the ability to tolerate chemotherapy.

3.There is measurable disease according to the RECIST 1.1 or irRECIST criteria. 4.The histological types can be serous, endometrioid, clear cell, mucinous or undifferentialed types of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. The original primary tumor needs to be histologically confirmed through the pathological report.

5.Participants can be either platinum-sensitive (with a platinum-free interval(PFI) of ≥6 months before the recent recurrence) or platinum-resistant (with a PFI of <6 months before the recent recurrence). If the participant has a platinum-sensitive disease, they can only participate in this clinical trial with platinum-based chemotherapy contraindications (such as severe persistent toxicity or a severe hypersensitivity reaction to platinum drugs, or refuse standard treatment).

6.The participants must be willing to undergo hollow needle biopsy or excisional biopsy of tumor lesion within 4 weeks (28 days) before the start of the treatment and after 3 cycles treatment. For participants who are unable to provide new samples (for example, unable to obtain or there are issues related to the safety of the participants), only with the consent of the principal investigator can archived samples be submitted.

Exclusion Criteria: