Ribociclib and Spartalizumab in R/M HNSCC

NCT04213404 | Unknown Phase 1 DMC

• 3 other identifiers: 201907017MIPDCPDR001A0TW01TRISE-HN
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

ribociclib; spartalizumab; PDR001; head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (2)

• Adverse events

  CTCAE 5.0

  28 days

• Objective response rate

  RECIST 1.1

  8 weeks

Secondary Outcomes (4)

• Progression free survival

  24 months

• Overall survival

  24 months

• Duration of response

  24 months

• Objective response rate (iRECIST)

  8 weeks

Study Arms (1)

Ribociclib-spartalizumab

EXPERIMENTAL

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

Drug: Ribociclib; Drug: Spartalizumab

Interventions

Ribociclib DRUG

Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle

Also known as: Kisqali

Ribociclib-spartalizumab

Spartalizumab DRUG

Spartalizumab 400mg ivdrip on D1, 28 days a cycle.

Also known as: PDR001

Ribociclib-spartalizumab

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx.
• The recurrent disease is not suitable for curative surgery or definitive chemoradiation, and/or metastatic diseases which are not amenable to surgery and/or curative radiotherapy.
• Measurable disease according to RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Age: older than 20 years-old, and younger than 70 years-old
• ECOG performance status: ≤ 1
• Adequate organ function,
• Recovered from any previous therapy related toxicity to ≤Grade 1 at study entry (except for stable sensory neuropathy ≤Grade 2 and alopecia)
• Patient must have the following laboratory values within local normal range or corrected to within local normal range with supplements before the first dose of study medication:
• Sodium
• Potassium
• Magnesium
• Total Calcium (corrected for serum albumin)
• Phosphorus
• Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the local laboratory
• QTcF interval at screening \< 450 msec (using Fridericia's correction)

You may not qualify if:

• Nasopharyngeal carcinoma or nasal cavity malignancies other than HNSCC
• For patients with oropharyngeal cancer, positive p16 immunohistochemical (IHC) stain is excluded.
• The positivity of p16 IHC is defined as p16 IHC expression ≥ 70
• Concurrent malignancies other than HNSCC
• Can not take a complete tablet orally.
• Hypercalcemia \[corrected serum calcium \> upper limits of normal (ULN)\] in recent 42 days.
• Prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors
• Prior exposure to ribociclib, palbociclib, or abemaciclib.
• Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as detectable HCV RNA) infection.
• Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Has an active infection requiring systemic therapy 14 days before signing informed consent.
• Has received prior radiotherapy within 4 weeks of signing informed consent.
• Major surgery within 4 weeks before signing informed consent.
• History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to signing informed consent.
• Has known history of pneumonitis requiring steroids, or any evidence of active, non-infectious pneumonitis, or other known interstitial lung disease

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Novartis: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

ribociclib; spartalizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Hsiang-Fong Kao, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: single arm, phase I study with dose titration plan.

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 30, 2019
• Study Start: March 13, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)