Ribociclib and Spartalizumab in R/M HNSCC

Sponsor
National Taiwan University Hospital
Study ID
NCT04213404
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle
  • Spartalizumab — DRUG
    Spartalizumab 400mg ivdrip on D1, 28 days a cycle.

Study Details

This study examines the safety and efficacy of ribociclib (CDK 4/6 inhibitors) and spartalizumab (anti-PD1) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Key Dates

Start date
Mar 13, 2020
Status verified
Apr 2022
Primary completion
Jan 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib-spartalizumab
    Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle Spartalizumab 400mg ivdrip on D1, 28 days a cycle.

Primary Outcome Measure

Adverse events [ Time Frame: 28 days ]

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