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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 prior Anti-PD-1/PD-L1 therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab and IBI310 (single arm) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | (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. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective response rate) | Investigator evaluated ORR per RECIST V1.1 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DOR(Duration of Response) | defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first; | Up to 2 years |
| PFS (Progress Free Survival) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| IBI310 | Drug | (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. |
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defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;
| Up to 2 years |
| OS (Overall Survival) | 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; | Up to 2 years |
| DCR(Disease control rate) | defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD | Up to 2 years |
| TTR(Time to progress) | defined as the time from randomization to the first documented and confirmed objective response (CR or PR) | Up to 2 years |
| TEAE(Treatment Emergent Adverse Event)/SAE(Serious Adverse Event) | 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; | Up to 2 years |
| Changes of Quality of life, according to EORTC QLQ-C30 | According to EORTC QLQ-C30 | Up to 2 years |
| Changes of Quality of life, according to EORTC QLQ-H&N35 | According to EORTC QLQ-H&N35 | Up to 2 years |
| ADAs | The immunogenicity of IBI310 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs) | Up to 2 years |