Ovarian CancerPhase 2BACONNCT07489300

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

A Phase 2 study testing Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide in people with Ovarian Cancer and Fallopian Tube Cancers, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer
What is being tested?: Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: 30 Mar 2026to 31 Jan 2028
Phase: Phase 2

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

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.

Who cannot join

About this study

Conditions: Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer
Being tested: Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide
Keywords: Benmelstobart, Anlotinib, oral metronomic Cyclophosphamide, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer
Medical subject headings: Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07489300
Study group	Role	What they receive
Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide	Other	Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial OvariaN, fallopian tube, or primary peritoneal cancer Receives: Drug: Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

CRR
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).
Measured: 6 months
OS
OS is defined as the time from the date of randomization until death
Measured: 5 years
AEs
Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 202631 Jan 2028

First posted24 Mar 2026
Study start30 Mar 2026 (estimated)
Primary completion31 Jan 2027 (estimated)
Study completion31 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07489300
Sponsor's protocol ID: BACON study
Acronym: BACON
Status last verified: Jul 2025
First submitted: 19 Mar 2026
Last updated: 24 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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