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Head and Neck Squamous Cell CarcinomaPhase 1RISE-HNNCT04213404

Ribociclib and Spartalizumab in R/M HNSCC

A Phase 1 study testing Ribociclib and Spartalizumab in people with Head and Neck Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Ribociclib and Spartalizumab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteTaiwan
Study dates
13 Mar 2020to Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

About this study

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

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).

Read the 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.

Being tested
Ribociclib, Spartalizumab
Keywords
ribociclib, spartalizumab, PDR001, head and neck squamous cell carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibociclibDrug

    Also called Kisqali

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

  • SpartalizumabDrug

    Also called PDR001

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

Study groups in NCT04213404
Study groupRoleWhat they receive
Ribociclib-spartalizumabExperimentalRibociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle Spartalizumab 400mg ivdrip on D1, 28 days a cycle.
Receives: Drug: Ribociclib; Drug: Spartalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    CTCAE 5.0

    Measured: 28 days

  2. Objective response rate

    RECIST 1.1

    Measured: 8 weeks

Secondary outcomes (4)

  1. Progression free survival

    from study entry to disease progression or death

    Measured: 24 months

  2. Overall survival

    from study entry to death

    Measured: 24 months

  3. Duration of response

    from response to disease progression

    Measured: 24 months

  4. Objective response rate (iRECIST)

    iRECIST

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2019
  2. Study start13 Mar 2020
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
single arm, phase I study with dose titration plan.
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04213404
Sponsor's protocol ID
201907017MIPD
Other IDs
CPDR001A0TW01T, RISE-HN
Acronym
RISE-HN
Status last verified
Apr 2022
First submitted
23 Dec 2019
Last updated
21 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ribociclib and Spartalizumab in people with Head and Neck Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04213404.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.

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