NCT04611321

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

October 27, 2020

Last Update Submit

March 24, 2023

Conditions

Advanced Cutaneous Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome

    RECIST version 1.1 will be used to determine ORR by IRRC

    24 months

Secondary Outcomes (5)

  • Investigator Assessments of Overall Response Rate

    24 months

  • Duration of response

    24 months

  • PFS (progression-free survival)

    24 months

  • Overall Survival

    24 months

  • AEs and SAEs

    30 months

Study Arms (1)

Phase Ib/II

EXPERIMENTAL

Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.

Drug: IBI318

Interventions

IBI318DRUG

IBI318 will be given fixed dose via intravenous (IV) infusion on Day 1 of each 14-day cycle until disease progression or loss of clinical benefit.

Phase Ib/II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and willing to sign the ICF.
  • Adults 18 years of age or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy at least 12 weeks.
  • Adequate organ and bone marrow function.
  • Histologically confirmed diagnosis of invasive CSCC. .

You may not qualify if:

  • Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
  • Any investigational drugs received within 4 weeks prior to the first study treatment.
  • Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
  • History of autoimmune disease , present active autoimmune disease or inflammatory diseases
  • Pregnant or nursing females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Study Design

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

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 2, 2020

Study Start

December 1, 2020

Primary Completion

March 10, 2023

Study Completion

March 10, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

CN(1)