A Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squamous Cell Cancer

NCT04856631 | Unknown Phase 1

• 1 other identifier: JS001-037-Ib/II-HNSCC
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase Ib/II, open-label, multicenter clinical trial. Here, the study phase Ib is mainly to evaluate safety of combination regimen of Toripalimab and Cetuximab in treatment of relapsed or metastatic HNSCC failing first-line platinum-based therapy and determine the recommended Phase II dose (RP2D); the study phase II is divided into two cohorts. Cohort A used to evaluate the efficacy and safety of the combination of regimen for relapsed or metastatic HNSCC failing first-line platinum-based regimen containing chemotherapy;cohort B used to evaluate the efficacy and safety of the combination regimen for PD-L1-positive HNSCC that have not received prior systemic therapy for relapsed or metastatic disease.

Conditions

Head and Neck Squamous Cell Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate(ORR)evaluated by RECIST 1.1-Phase2

  Evaluate efficacy of the combination therapy in treatment of relapsed or metastatic HNSCC in accordance with the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as objective response rate (ORR) evaluated

  Up to 2 years

• Incidence and severity of adverse event (AE) and serious adverse event (SAE)-Phase1

  Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE V5.0; and abnormalities in vital signs, ECG and laboratory tests, etc.

  Up to 2 years

Secondary Outcomes (4)

• Objective response rate(ORR)evaluated by the investigator-Phase2

  Up to 2 years

• Disease control rate（DCR）and Duration of response（DOR）and progression-free survival (PFS).-Phase2

  Up to 2 years

• Overall survival（OS）

  Up to 2 years

• Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE V5.0

  Up to 2 years

Other Outcomes (1)

• Recommended Phase 2 dose (RP2D)-Phase1

  Up to 2 years

Study Arms (1)

Experimental group

EXPERIMENTAL

Toripalimab Injection (JS001) + Cetuximab

Drug: Toripalimab Injection; Drug: Cetuximab Solution for infusion

Interventions

Toripalimab Injection DRUG

240mg once per 3 weeks

Experimental group

Cetuximab Solution for infusion DRUG

First infusion 400mg/m2，Subsequent infusions 250mg/m2。once per week

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase II cohort B:
• No previous systemic treatment for relapsed or metastatic disease. Relapse or metastasis more than 6 months after the end of treatment if previously treated with systemic therapy as part of local treatment.
• Qualified tumor tissue samples with positive PD-L1 expression (defined as Combined Positive Score (CPS) ≥ 1) tested by the central laboratory are required.

You may not qualify if:

• \. Previous tumor samples or fresh tumor tissue biopsy samples may be provided.
• For subjects with oropharyngeal cancer, a prior test report for HPV16 may be provided, or eligible tumor tissue samples are provided to test HPV status.
• \. At least one measurable lesion in accordance with RECIST 1.1 assessment criteria;
• Patients with life expectancy \>=12 weeks;
• \. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 point;
• \. Good organ function level:
• System organ Lab Value
• Hematology (no blood transfusion or colony-stimulating factor or other drug correction within 14 days prior to the first study dose)
• Neutrophil count ≥1.5×10\^9/L
• Platelet count ≥100×10\^9/L
• Hemoglobin ≥90 g/L
• Kidney function
• Serum creatinine \<=1.5 x upper limit of normal (ULN) or Creatinine clearance is calculated with reference to the Cockcroft-Gault formula or the site practices ≥50 mL/min
• Hepatic function
• total Bilirubin \<=1.5 x ULN or\<=3 x ULN (patients with known Gilbert's disease)

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Ye Guo, Doctor

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

peng zhou, Project Manager

CONTACT

86 18013002767; peng_zhou@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: April 23, 2021
• Study Start: April 6, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2023
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

CN (1)