Clinical trial NCT04945421: IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NPC
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: ORR(Objective response rate)
timeFrame: Up to 2 years
Secondary outcomes:
measure: DOR(Duration of Response)
timeFrame: Up to 2 years
measure: PFS (Progress Free Survival)
timeFrame: Up to 2 years
measure: OS (Overall Survival)
timeFrame: Up to 2 years
measure: DCR(Disease control rate)
timeFrame: Up to 2 years
measure: TTR(Time to progress)
timeFrame: Up to 2 years
measure: TEAE(Treatment Emergent Adverse Event)/SAE(Serious Adverse Event)
timeFrame: Up to 2 years
measure: Changes of Quality of life, according to EORTC QLQ-C30
timeFrame: Up to 2 years
measure: Changes of Quality of life, according to EORTC QLQ-H&N35
timeFrame: Up to 2 years
measure: ADAs
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: