IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC
Study Details
Study Description
Brief Summary
This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed to prior Anti-PD-1/PD-L1 therapy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sintilimab and IBI310 (single arm) The test group will be treated with either (IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first. |
Drug: Sintilimab
(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
Drug: IBI310
(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
|
Outcome Measures
Primary Outcome Measures
- ORR(Objective response rate) [Up to 2 years]
Investigator evaluated ORR per RECIST V1.1
Secondary Outcome Measures
- DOR(Duration of Response) [Up to 2 years]
defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;
- PFS (Progress Free Survival) [Up to 2 years]
defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;
- OS (Overall Survival) [Up to 2 years]
defined as the time from randomization to death of any cause in subjects without receiving any immunotherapy outside the study protocol for first-line treatment of advanced HCC;
- DCR(Disease control rate) [Up to 2 years]
defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD
- TTR(Time to progress) [Up to 2 years]
defined as the time from randomization to the first documented and confirmed objective response (CR or PR)
- TEAE(Treatment Emergent Adverse Event)/SAE(Serious Adverse Event) [Up to 2 years]
Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0, 2017) grade;
- Changes of Quality of life, according to EORTC QLQ-C30 [Up to 2 years]
According to EORTC QLQ-C30
- Changes of Quality of life, according to EORTC QLQ-H&N35 [Up to 2 years]
According to EORTC QLQ-H&N35
- ADAs [Up to 2 years]
The immunogenicity of IBI310 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged ≥18 years;
-
ECOG 0 ~ 1;
-
Histologically/cytologically confirmed R/M NPC;
-
Failed to prior Anti-PD-1 resistance;
-
Adequate organ and bone marrow function;
-
Expected survival ≥12 weeks;
-
Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;
-
Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
-
At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).
Exclusion Criteria:
-
Had tumors other than NPC within the past 5 years.
-
Had allogeneic organ or stem cell transplantation.
-
The presence of uncontrolled life-threatening illness
-
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
-
Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
-
HIV positive.
-
Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
-
Severe, uncontrolled medical conditions and infections.
-
At the same time using other test drugs or in other clinical trials.
-
Refusal or inability to sign informed consent to participate in the trial.
-
Other treatment contraindications.
-
Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
-
Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
-
Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI310F201