Endometrial CancerPhase 2IMMUNE-SAVENCT07369986
Immunotherapy for Surgery Avoidance in Vulnerable dMMR Endometrial Cancer
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706) in people with Endometrial Cancer and Immunotherapy, run by Women's Hospital School Of Medicine Zhejiang University.
Trial summary
Efficacy evaluate of iparomlimab and tuvonralimab (a PD-1/CTLA-4 bispecific antibody) in patients with surgically resectable dMMR endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Immunotherapy, Mismatch Repair Deficiency
- What is being tested?
- Iparomlimab and Tuvonralimab (QL1706)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2028
- Phase
- Phase 2
- 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
- Age:18 years or older.
- Histologically confirmed endometrial cancer (excluding carcinosarcoma).
- FIGO (2009) stage I to IIIC2 disease that is considered surgically completely resectable.
- Confirmed dMMR or MSI-H, defined by either loss of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6 or MSI-H) for by immunohistochemistry, or MSI-H status confirmed by polymerase chain reaction assay.
- 5)No prior systemic anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, or immunotherapy) within the past 5 years.
- 6)Eastern Cooperative Oncology Group Performance Status of 0 or 1. 7)Laboratory test results within 7 days prior to the first dose must meet the following criteria. Laboratory values are not valid if the patient received granulocyte colony-stimulating factor or a blood transfusion within 14 days prior to sample collection.
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- White blood cell count ≥2,000/mm3 and absolute neutrophil count ≥1,500/mm3. Platelet count ≥100,000/mm3. Hemoglobin ≥9.0 g/dL.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0-fold of the upper limit of normal (ULN) (or ≤5.0-fold the ULN of the study site in patients with liver metastases). Total bilirubin ≤1.5-fold of the ULN.
- Creatinine ≤1.5-fold of the ULN or creatinine clearance (either the measured or estimated value using the Cockcroft-Gault equation) ≥ 45 mL/min.
- 8)Women of childbearing potential:
- Must agree to use contraception from the time of informed consent until at least 5 months after the last dose of the investigational product.
- Must agree not to breastfeed from the time of informed consent until at least 5 months after the last dose.
Who cannot join
- 1)Multiple primary malignancies, except for: adequately resected basal cell or squamous cell carcinoma of the skin (Stage I), superficial bladder cancer, or any other malignancy that has been disease-free for over 5 years.
- History of severe hypersensitivity to any monoclonal antibody. 3)Known hypersensitivity to iparomlimab and tuvonralimab or any of their excipients.
- 4)Concurrent or history of clinically significant autoimmune disease. 5)Current or prior interstitial lung disease or pulmonary fibrosis documented by imaging or clinical assessment. Patients with radiation pneumonitis may be enrolled if it is confirmed to be stable (beyond the acute phase) and without anticipated recurrence.
- 6)Concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease. 7)Symptomatic pericardial effusion, pleural effusion, or ascites requiring treatment.
- 8)Uncontrolled tumor-related pain. 9)Transient ischemic attack, cerebrovascular accident, or thromboembolism within 180 days prior to enrollment.
- 10)Uncontrolled or clinically significant cardiovascular disease, defined as any of the following within 180 days prior to enrollment:
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- Myocardial infarction;
- Unstable angina pectoris;
- Congestive heart failure of New York Heart Association (NYHA) Class III or IV
- Poorly controlled hypertension despite appropriate treatment (e.g., sustained systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg for ≥ 24 hours)
- Arrhythmia requiring treatment 11)Requirement for ongoing therapeutic anticoagulation (low-dose aspirin or other antiplatelet therapy is permitted).
- 12)Poorly controlled diabetes mellitus. 13)Active systemic infection requiring treatment. Systemic corticosteroid therapy (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before enrollment.
- 15)Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular targeted therapy agents, or immunotherapy agents) within 28 days before randomization.
- 16)Surgical pleurodesis or pericardium within 28 days prior to enrollment. 17)Major surgery within 4 weeks or minor surgery within 7 days before the first dose, without full recovery. Patients scheduled for major surgery during the study period are excluded (video-assisted thoracoscopic surgery or diagnostic procedures are not considered exclusions if recovery is adequate).
- 18)Administration of any therapeutic radiopharmaceutical within 56 days prior to enrollment (diagnostic use is permitted).
- 19)Active tuberculosis. 20)Positive serology for human immunodeficiency virus (HIV-1/2 antibody), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody. Patients who are HBsAg-positive may be enrolled if hepatitis B virus DNA is below the lower limit of detection.
- 21)Any other severe medical or psychiatric condition, or abnormal laboratory findings, that in the investigator's judgment would increase the risk of study participation, compromise protocol compliance, or interfere with the interpretation of study results.
- 22)Participation in another clinical trial and receipt of an investigational product within 4 weeks prior to the first dose.
- 23)Pregnancy, lactation, or intention to become pregnant during the study period.
- 24)Positive urine pregnancy test within 72 hours before treatment initiation (if urine test is positive or indeterminate, a confirmatory serum pregnancy test is required).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2b, Open-Label Study of Iparomlimab and Tuvonralimab to Facilitate Surgery Avoidance in Women With Resectable, Mismatch Repair-Deficient Endometrial Cancer
Efficacy evaluate of iparomlimab and tuvonralimab (a PD-1/CTLA-4 bispecific antibody) in patients with surgically resectable dMMR endometrial cancer.
- Being tested
- Iparomlimab and Tuvonralimab (QL1706)
- Medical subject headings
- Endometrial Neoplasms, Turcot syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab (QL1706)Drug
Iparomlimab and Tuvonralimab as a strategy to facilitate non-surgical management in women with surgically completely resectable dMMR endometrial cancer.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy | Experimental | Not described Receives: Drug: Iparomlimab and Tuvonralimab (QL1706) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological or clinical complete response rate
Measured: From the time of enrollment until 12 months after the completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369986
- Sponsor's protocol ID
- PRO2025-811
- Acronym
- IMMUNE-SAVE
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Open-Label Study of Iparomlimab and Tuvonralimab to Facilitate Surgery Avoidance in Women With Resectable, Mismatch Repair-Deficient Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07369986
- Acronym / sponsor ID
- IMMUNE-SAVE / PRO2025-811
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jan 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.
Efficacy evaluate of iparomlimab and tuvonralimab (a PD-1/CTLA-4 bispecific antibody) in patients with surgically resectable dMMR endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy | Experimental | Drug: Iparomlimab and Tuvonralimab (QL1706) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age:18 years or older.
- Histologically confirmed endometrial cancer (excluding carcinosarcoma).
- FIGO (2009) stage I to IIIC2 disease that is considered surgically completely resectable.
- Confirmed dMMR or MSI-H, defined by either loss of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6 or MSI-H) for by immunohistochemistry, or MSI-H status confirmed by polymerase chain reaction assay.
- 5)No prior systemic anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, or immunotherapy) within the past 5 years.
Key exclusion criteria (20 listed)
- 1)Multiple primary malignancies, except for: adequately resected basal cell or squamous cell carcinoma of the skin (Stage I), superficial bladder cancer, or any other malignancy that has been disease-free for over 5 years.
- History of severe hypersensitivity to any monoclonal antibody. 3)Known hypersensitivity to iparomlimab and tuvonralimab or any of their excipients.
- 4)Concurrent or history of clinically significant autoimmune disease. 5)Current or prior interstitial lung disease or pulmonary fibrosis documented by imaging or clinical assessment. Patients with radiation pneumonitis may be enrolled if it is confirmed to be stable (beyond the acute phase) and without anticipated recurrence.
- 6)Concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease. 7)Symptomatic pericardial effusion, pleural effusion, or ascites requiring treatment.
- 8)Uncontrolled tumor-related pain. 9)Transient ischemic attack, cerebrovascular accident, or thromboembolism within 180 days prior to enrollment.
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 |
|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706)Iparomlimab and Tuvonralimab as a strategy to facilitate non-surgical management in women with surgically completely resectable dMMR endometrial cancer. | Drug | Immunotherapy |
Primary outcome
Pathological or clinical complete response rate
Time frame: From the time of enrollment until 12 months after the completion of treatment
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 27 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706) in people with Endometrial Cancer and Immunotherapy, run by Women's Hospital School Of Medicine Zhejiang University.
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 12 inclusion and 20 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: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yang Li (+86-571-87061501, li_yang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological or clinical complete response rate (time frame: From the time of enrollment until 12 months after the completion of treatment). 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 27 Jan 2026.