A Single-arm, Open-label, Multi-center Clinical Trial of Iparomlimab and Tuvonralimab (QL1706, Anti-PD-1 /CTLA-4 Combination Antibody) Combined with Chemotherapy in the Treatment of Recurrent or Metastatic Endometrial Cancer
Overview
- Phase
- Phase 2
- Intervention
- QL1706 plus carboplatin plus paclitaxel for six to eight cycles at the investigator's discretion, followed by QL1706
- Conditions
- Recurrent or Metastatic Endometrial Cancer
- Sponsor
- xiang yang
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- ORR
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
the investigators planned to evaluate the efficacy and safety of QL1706 in combination with chemotherapy as first-line systemic therapy in approximately 26 patients with newly diagnosed recurrent or metastatic endometrial cancer in a single-arm, open-label, multicenter study.
The main questions it aims to answer are:
Evaluate the efficacy and safety of QL1706 plus chemotherapy as first-line systemic therapy for recurrent or metastatic disease.
According to the treatment regimen, a total of 26 subjects were enrolled. Eligible subjects received QL1706 (5mg/kg, Q3W, d1) plus carboplatin (AUC=5, Q3W, d1) plus paclitaxel (175mg/m2, Q3W, d1) for six to eight cycles at the investigator's discretion, followed by QL1706 (5mg/kg, Q3W, d1). d1) until disease progression, development of unacceptable toxicity, lack of benefit as judged by the investigator, withdrawal of consent, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.
Investigators
xiang yang
Peking Union Medical College Hospital
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign a written ICF.
- •The age at enrollment was ≥18 years old, ≤75 years old, female.
- •Eastern Cooperative Oncology (ECOG) performance status of 0 or
- •Expected survival time ≥3 months.
- •Histologically confirmed stage III/IV or recurrent endometrial cancer, who have not received first-line systemic anticancer therapy, and are not suitable for other treatments other than systemic therapy (e.g., unable or unable to tolerate surgery, unsuitable for radiotherapy, etc.).
- •Presence of measurable lesions as required by: a) at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1); Lymph nodes with the long diameter of non-lymph node lesions ≥10mm or the short diameter of lymph node lesions ≥15mm can be measured repeatedly. b) Lesions receiving external beam radiation therapy (EBRT) or locoregional therapy (such as radiofrequency ablation) must show subsequent evidence of substantial size increase to be considered target lesions.
- •Good function of major organs:
- •Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days before the first dose of medication (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test should be performed, and the result is negative). If a female subject of childbearing potential has sex with an unsterilized male partner, the subject must be using an acceptable method of contraception from the time of screening and must agree to continue using contraception for 120 days after the last dose of study drug. Discontinuation of contraception after this time point should be discussed with the investigator.
- •Participants were willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.
Exclusion Criteria
- •Participated in treatment with the investigational drug or used the investigational device within 4 weeks before the first dose of QL
- •Enroll in another clinical study at the same time, unless it is the follow-up period of an observational (nonintervention) clinical study or an intervention study (defined as the first dose of the study drug is more than 4 weeks after the last dose of the previous clinical study or more than 5 half-lives of the study drug, whichever is the longest).
- •Carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma or other high-grade sarcoma, or endometrial stromal sarcoma.
- •Patients with other active malignant tumors within 2 years before enrollment. Exclusions were made for locally curable malignancies that appeared cured, such as squamous cell carcinoma of the basal or skin, superficial bladder cancer, and carcinoma in situ of the cervix or breast.
- •Active autoimmune disease requiring systemic treatment within 2 years before the initiation of study treatment, or autoimmune disease with potential recurrence or planned treatment as judged by the investigator; Exceptions include skin diseases that do not require systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); Hypothyroidism due to autoimmune thyroiditis requires only stable doses of hormone replacement therapy. Well-controlled type I diabetes; Subjects who have had complete remission of childhood asthma without any intervention in adulthood; The investigator judged that the disease would not recur in the absence of an external trigger.
- •Inflammatory bowel disease associated with active disease or requiring clinical management (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
- •History of a known positive test for human immunodeficiency virus or a known positive test for acquired immunodeficiency syndrome.
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Known presence or history of interstitial lung disease.
- •History of gastrointestinal perforation and/or fistula within 6 months before enrollment.
Arms & Interventions
Experimental
QL1706（iparomlimab and tuvonralimab a bifunctional MabPair® product of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 antibodies） plus carboplatin and paclitaxel for six to eight cycles at the investigator's discretion, followed by QL1706 until disease progression, development of unacceptable toxicity, lack of benefit as judged by the investigator, withdrawal of consent, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.
Intervention: QL1706 plus carboplatin plus paclitaxel for six to eight cycles at the investigator's discretion, followed by QL1706
Outcomes
Primary Outcomes
ORR
Time Frame: up to 5 months
The best overall response (BOR) was defined as the proportion of subjects who achieved a confirmed CR or PR (according to RECIST v1.1).
Secondary Outcomes
- PFS(up to 13months)
- DoR(up to 5 months)
- OS(up to 45 months)