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

NPC Clinical Trial

Official title:

The Phase Ib/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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04945421
• Other study ID #: CIBI310F201
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2021
• Est. completion date: February 6, 2023

Study information

• Verified date: February 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 6, 2023
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• NPC

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR(Objective response rate)	Investigator evaluated ORR per RECIST V1.1	Up to 2 years
Secondary	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
Secondary	PFS (Progress Free Survival)	defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;	Up to 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes of Quality of life, according to EORTC QLQ-C30	According to EORTC QLQ-C30	Up to 2 years
Secondary	Changes of Quality of life, according to EORTC QLQ-H&N35	According to EORTC QLQ-H&N35	Up to 2 years
Secondary	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