Δευτέρα 30 Δεκεμβρίου 2019

Ribociclib and Spartalizumab in R/M HNSCC

Ribociclib and Spartalizumab in R/M HNSCC: Condition:   Head and Neck Squamous Cell Carcinoma Interventions:   Drug: Ribociclib;   Drug: Spartalizumab Sponsors:   National Taiwan University Hospital;   Novartis Recruiting (Source: ClinicalTrials.gov)

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Ribociclib and Spartalizumab in R/M HNSCC (RISE-HN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04213404

Recruitment Status  : Recruiting

First Posted  : December 30, 2019

Last Update Posted  : December 30, 2019

See Contacts and Locations

Sponsor:

National Taiwan University Hospital

Collaborator:

Novartis

Information provided by (Responsible Party):

National Taiwan University Hospital



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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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).



Condition or disease Intervention/treatment Phase

Head and Neck Squamous Cell Carcinoma

Drug: Ribociclib

Drug: Spartalizumab

Phase 1



Detailed Description:

The study is a phase I study testing ribociclib (with dose titration plan) and spartalizumab (fixed dose) for R/M HNSCC. The primary endpoints are safety and objective response rate.



Study Design

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Study Type  : Interventional  (Clinical Trial)

Estimated Enrollment  : 13 participants

Intervention Model: Single Group Assignment

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

Masking: None (Open Label)

Primary Purpose: Treatment

Official Title: Ribociclib and Spartalizumab for Head and Neck Squamous Cell Carcinoma, a Phase I Study With Expansion Cohort (RISE-HN)

Estimated Study Start Date  : January 2020

Estimated Primary Completion Date  : January 2024

Estimated Study Completion Date  : January 2025

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Head and neck squamous cell carcinoma

Drug Information available for: Ribociclib

U.S. FDA Resources



Arms and Interventions

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Arm Intervention/treatment

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.

Drug: Ribociclib

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

Other Name: Kisqali



Drug: Spartalizumab

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

Other Name: PDR001







Outcome Measures

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Primary Outcome Measures  :

Adverse events [ Time Frame: 28 days ]

CTCAE 5.0



Objective response rate [ Time Frame: 8 weeks ]

RECIST 1.1





Secondary Outcome Measures  :

Progression free survival [ Time Frame: 24 months ]

from study entry to disease progression or death



Overall survival [ Time Frame: 24 months ]

from study entry to death



Duration of response [ Time Frame: 24 months ]

from response to disease progression



Objective response rate (iRECIST) [ Time Frame: 8 weeks ]

iRECIST





Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





Ages Eligible for Study:  20 Years to 70 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:



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)

Mean resting heart rate 50-100 bpm (determined from the ECG)

Agree to take biopsy before and during the treatment

The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.

Female subject of childbearing potential should have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:



Not a woman of childbearing potential (WOCBP) OR

A WOCBP who agrees to have the contraceptive during the treatment period and for at least 120 days after the last dose of study treatment

A male participant must agree to use a contraception of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.

Exclusion Criteria:



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

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.

Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Topical or inhaled steroids is not considered as systemic treatment.

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug

Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.

Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption)

Known brain metastases or leptomeningeal carcinomatosis

History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213404





Contacts

Contact: Hsiang-Fong Kao, MD +886223123456 hfkao.tw@gmail.com



Locations

Taiwan

National Taiwan University Hospital Recruiting

Taipei, Taiwan, 10002

Contact: Hsiang-Fong Kao, MD    +886-2-23123456    hfkao.tw@gmail.com 

Sponsors and Collaborators

National Taiwan University Hospital

Novartis

Investigators

Principal Investigator: Hsiang-Fong Kao, MD National Taiwan University Hospital

More Information

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Responsible Party: National Taiwan University Hospital

ClinicalTrials.gov Identifier: NCT04213404     History of Changes

Other Study ID Numbers: 201907017MIPD

CPDR001A0TW01T ( Other Grant/Funding Number: Novartis )

RISE-HN ( Other Identifier: Taiwan FDA )

First Posted: December 30, 2019    Key Record Dates

Last Update Posted: December 30, 2019

Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Taiwan University Hospital:

ribociclib

spartalizumab

PDR001

head and neck squamous cell carcinoma

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Neoplasms by Site





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