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Head and Neck Squamous Cell CarcinomaPhase 1/2NCT04193293

A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

A Phase 1/2 study testing Duvelisib and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma, run by SecuraBio at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study was designed to assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Duvelisib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
1 Jun 2020to 10 Dec 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group performance status ≤ 1
  • Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx that was considered incurable by local therapies
  • Eligible for pembrolizumab monotherapy based on the current prescribing information for pembrolizumab (Keytruda 2019)
  • Must have had 0 to 2 prior therapies for R/M HNSCC
  • At least 1 measurable lesion (which has not been previously irradiated) according to Response Evaluation Criteria in Solid Tumors version 1.1
  • For stage 1 only: Must have had at least 1 other lesion that could be biopsied and willing to undergo a pretreatment and on-treatment biopsy of the available tumor lesion
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  • For stage 1 only: Must have been willing to undergo a pretreatment and on-treatment biopsy of the available tumor lesion
  • Adequate organ function defined by the following laboratory parameters:
  • Absolute neutrophil count ≥ 1.5 × 10^9/liter (L)
  • Platelet count ≥ 100 × 10^9/L
  • Hemoglobin level ≥ 9.0 grams/deciliter (dL)
  • A serum creatinine level < 1.5 milligrams/dL, or
  • Estimated creatinine clearance value ≥ 60 milliliters/minute (as determined by the Cockcroft-Gault method) for participants with creatinine levels > 1.5 × institutional upper limit of normal (ULN)
  • Total bilirubin level ≤ 1.5 × ULN (exception: participants with Gilbert's Syndrome may have a bilirubin level > 1.5 × ULN)
  • Aspartate aminotransaminase/serum glutamic-oxaloacetic transaminase and alanine aminotransferase/serum pyruvic transaminase levels ≤ 2.5 × ULN or ≤ 5 × ULN in participants with liver metastases
  • International normalized ratio or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, unless participant was receiving anticoagulant therapy in which case PT or aPTT must have been within therapeutic range of intended use of anticoagulants

Who cannot join

  • Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease
  • Received anticancer treatment, major surgery, or any investigational drug within 30 days or 5 half-lives, whichever is shorter, before the start of study intervention
  • Received radiation therapy within 14 days before the start of study intervention, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation; Palliative radiation is allowed if > 7 days and any toxicity is ≤ Grade 1
  • Previous treatment with a PI3K, PD-1 or programmed cell death ligand 1 inhibitor
  • Have received organ or allogenic bone marrow or peripheral blood stem cell transplant
  • History of drug-induced colitis or drug-induced pneumonitis; history or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function; tuberculosis treatment within 2 years prior to the start of study intervention; chronic liver disease or veno-occlusive disease/sinusoidal obstruction syndrome
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  • Active cytomegalovirus or Epstein-Barr virus infection; history of or known human immunodeficiency virus infection
  • Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A. No prior use within 2 weeks before the start of study intervention Received a live or live attenuated vaccine within 6 weeks of first dose of duvelisib
  • Unable to receive prophylactic treatment for pneumocystis, HSV, or VZV at screening
  • Any active gastrointestinal dysfunction interfering with the participant's ability to be administered oral medications
  • Known active central nervous system metastases and/or carcinomatous meningitis
  • QT interval > 500 milliseconds (except for participants with a right or left bundle branch block)
  • New York Heart Association Class III or IV congestive heart failure

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Phase 1b/2 Study of Duvelisib in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

This study was designed to assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Read the detailed description

This was a non-randomized, open-label Phase 1b/2 study designed to evaluate safety, tolerability, and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with R/M HNSCC who were eligible for pembrolizumab monotherapy based on the current pembrolizumab prescribing information.

Being tested
Duvelisib, Pembrolizumab
Keywords
Squamous Cell Carcinoma of the Head and Neck, Head and Neck Cancer, PI3K-δ,γ, PI3K Inhibitor
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

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

  • DuvelisibDrug

    Also called VS-0145, Copiktra

    Phosphoinositide 3-kinase (PI3K) Inhibitor

  • PembrolizumabBiological

    Also called PD-1 inhibitor, anti-PD-1, Keytruda

    Immunotherapy (programmed cell death protein 1 [PD-1] inhibitor)

Study groups in NCT04193293
Study groupRoleWhat they receive
Duvelisib + PembrolizumabExperimentalStage 1: Duvelisib twice daily (BID) for 1 week followed by combination therapy with duvelisib BID + pembrolizumab every 3 weeks (q3w) (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks). Stage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.
Receives: Drug: Duvelisib; Biological: Pembrolizumab

What is being measured

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

  1. Stage 1: Number of Participants With Dose-limiting Toxicities

    Measured: 4 weeks or 28 days

  2. Stage 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Number of participants with TEAEs as assessed by the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) as a measure of safety and tolerability of duvelisib in combination with pembrolizumab.

    Measured: 6 months

  3. Stage 1 and 2: Overall Response Rate (ORR)

    Proportion of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1).

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Stage 1: ORR

    Proportion of participants achieving complete CR or PR according to RECIST v 1.1.

    Measured: Until documented progressive disease (PD), unacceptable toxicity, discontinuation criteria are met, withdrawal, or death (up to 2 years)

  2. Stage 1 and 2: Duration of Response (DOR)

    Time from response ≥ PR to documented disease progression according to RECIST v 1.1.

    Measured: From first response until documented PD (up to 2 years)

  3. Stage 1 and 2: Progression-free Survival (PFS)

    Time from start of treatment to documented disease progression according to RECIST v 1.1, or death due to any cause.

    Measured: From start of treatment until documented PD or death (up to 2.5 years)

  4. Stage 1 and 2: Overall Survival

    Time from start of treatment to death.

    Measured: From start of treatment until death (up to 2.5 years)

  5. Stage 1 and 2: Maximum Observed Concentration [Cmax]

    Pharmacokinetics (PK) parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and Population PK (POPPK) modeling.

    Measured: Up to 5 cycles (46 weeks)

  6. Stage 1 and 2: Area Under the Curve [AUC]

    PK parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and POPPK modeling.

    Measured: Up to 5 cycles (46 weeks)

  7. Stage 1 and 2: Number of Participants With TEAEs

    Number of participants with TEAEs as assessed by CTCAE v5.0.

    Measured: 24 months

Timeline

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

  1. First posted10 Dec 2019
  2. Study start1 Jun 2020
  3. Primary completion10 Dec 2020
  4. Study completion10 Dec 2020

Why it stopped: The study was terminated due to low enrollment.

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193293
Sponsor's protocol ID
VS-0145-130
Status last verified
Sep 2023
First submitted
4 Dec 2019
Last updated
21 Sep 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Duvelisib and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma, run by SecuraBio at 1 site in United States.

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 16 inclusion and 15 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: stopped early, as of the sponsor's last update on 21 Sep 2023. 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 United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Stage 1: Number of Participants With Dose-limiting Toxicities (time frame: 4 weeks or 28 days). The study lists 3 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 NCT04193293.

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 Sep 2023.

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