IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC

Phase 1

Completed

• Conditions: NPC
• Interventions: Drug: Sintilimab; Drug: IBI310

• Registration Number: NCT04945421
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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 prior Anti-PD-1/PD-L1 therapy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-30
• Study Start: 2021-07-23
• Primary Completion: 2022-04-25
• Status Verified: 2023-02
• Study Completion: 2023-02-06
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Aged ≥18 years;
2. ECOG 0 ~ 1;
3. Histologically/cytologically confirmed R/M NPC;
4. Failed to prior Anti-PD-1 resistance;
5. Adequate organ and bone marrow function;
6. Expected survival ≥12 weeks;
7. 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;
8. Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
9. At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).

Exclusion Criteria

1. Had tumors other than NPC within the past 5 years.
2. Had allogeneic organ or stem cell transplantation.
3. The presence of uncontrolled life-threatening illness
4. 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.
5. Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
6. HIV positive.
7. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
8. Severe, uncontrolled medical conditions and infections.
9. At the same time using other test drugs or in other clinical trials.
10. Refusal or inability to sign informed consent to participate in the trial.
11. Other treatment contraindications.
12. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
13. Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
14. Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sintilimab and IBI310 (single arm)	IBI310	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.
Sintilimab and IBI310 (single arm)	Sintilimab	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.

Primary Outcome Measures

Name	Time	Method
ORR(Objective response rate)	Up to 2 years	Investigator evaluated ORR per RECIST V1.1

Secondary Outcome Measures

Name	Time	Method
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;
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;
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
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)
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
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)
Changes of Quality of life, according to EORTC QLQ-H&N35	Up to 2 years	According to EORTC QLQ-H\&N35

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China