Sinonasal CancerPhase 1/2NCT05879484
Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS
A Phase 1/2 study testing pembrolizumab and valemetostat in people with Sinonasal Cancer and Squamous Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide. These cancers have different causes, with smoking/tobacco exposure and human papilloma virus infection being the most common. . Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Sinonasal Cancer, Squamous Non-small Cell Lung Cancer, Lung Cancer
- What is being tested?
- pembrolizumab and valemetostat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2025to 9 Jul 2025
- Phase
- Phase 1/2
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to valemetostat or pembrolizumab used in the study.
- Prior curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to the first dose of study drug(s).
- Prior systemic therapy (e.g., chemotherapy, immunomodulatory therapy, monoclonal antibody therapy, or investigational therapy) within 4 weeks, or 5 half-lives of the drug, whichever is longer, prior to the first dose of the study drug(s).
- History of previous treatment with EZH2 inhibition.
- Participants currently receiving any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A).
- Participants currently receiving any medications or substances that are P-gp inhibitors (e.g., amiodarone, clarithromycin, diltiazem, erythromycin, ketoconazole, itraconazole, propafenone, quinidine, and verapamil).
Show all 27Show fewer
- Consumption of foods and beverages that are strong CYP3A inhibitors or inducers (star fruit, Seville orange, Seville orange-containing foods and beverages, grapefruit, grapefruit-containing food or beverages) within 3 days prior to the first dose of study drug(s).
- Active immunosuppressive treatment equivalent to>10 mg of prednisone daily. Note: Short-course systemic corticosteroids (e.g., prevention/treatment for transfusion reaction) or use for a non-cancer indication (e.g., adrenal replacement) is acceptable.
- Cardiovascular diseases with the following criteria:
- 9.1 Evidence of prolongation of QT/corrected (QTc) interval (e.g., repeated episodes of QT corrected for heart rate using Fridericia s method [QTcF] >470 ms regardless of sex) (average of triplicate determinations) at screening
- 9.2 Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome
- 9.3 History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes
- 9.4 Uncontrolled arrhythmia (participants with asymptomatic, controllable atrial fibrillation may be enrolled), or asymptomatic persistent ventricular tachycardia at screening
- 9.5 Participant has clinically relevant bradycardia of less than 50 bpm at screening unless the participant has a pacemaker
- 9.6 History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers, within 6 months prior to treatment initiation
- 9.7 Myocardial infarction within 6 months prior to treatment initiation
- 9.8 Angioplasty or stent graft implantation within 6 months prior to treatment initiation
- 9.9 Uncontrolled angina pectoris within 6 months prior to treatment initiation
- 9.10 History of New York Heart Association (NYHA), https://www.merckmanuals.com/professional/multimedia/table/new-york-heart- association-nyha-classification-of-heart-failure) Class 3 or 4 congestive heart failure
- 9.11 Coronary/peripheral artery bypass graft within 6 months prior to treatment initiation
- 9.12 Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) at screening
- 9.13 Complete left bundle branch block at screening
- History of autoimmune disease with the exception of controlled thyroid disease, psoriasis not requiring medications, vitiligo, and alopecia.
- Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered as cured and does not require additional Standard of Care treatment, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer.
- Ongoing uncontrolled systemic bacterial, fungal, or viral infection currently requiring treatment with intravenous antibiotics, antivirals, or antifungals.
- Pregnancy (confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening).
- Uncontrolled intercurrent illness or situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase Ib/II Multicenter Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS
Background:
Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide. These cancers have different causes, with smoking/tobacco exposure and human papilloma virus infection being the most common. . When HNSCC occurs in people who are not infected with HPV, the cancers are more likely to return after treatment; when this happens, overall survival is only about 10 months, thus better treatments are needed.
Read more
Objective:
To test a combination treatment using 2 drugs (valemetostat and pembrolizumab) in people with HNSCC. Phase 1b of the study will determine a recommended dose of the 2 drugs and evaluate how safe the combination is.; this will include patients with HPV-positive and HPV-negative HNSCC, as well as squamous cell NSCLC that have progressed on anti-PD-1/anti-PD-L1 therapies.Phase II will determine how effective the combination is and will focus on patients with HPV-negative HNSCC.
Eligibility:
People aged 18 years and older with HPV-negative HNSCC, sinonasal carcinoma of the head and neck, or squamous non-small cell lung cancer (NSCLC).
Design:
Participants will be screened. They will have a physical exam. They will have blood and urine tests and tests of their heart function. They will have imaging scans. They may have a biopsy: A small sample of tissue will be removed from the tumor.
Treatment will be given in 21-day cycles.
Pembrolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will receive pembrolizumab on the first day of each cycle.
Valemetostat is a tablet taken by mouth. Participants will take the tablet once a day at home. They will record the date and time of each dose in a diary. They will also write down any adverse effects they experience.
Participants may remain in the study up to 2 years.
Read the detailed description
Background:
- Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide, with approximately 60,000 patients diagnosed annually in the United States.
- Only 14% of HNSCC patients have structural defects in the genes encoding for the human leukocyte antigens (HLA) class I components, while a higher percentage of these tumors show downregulation of HLA class I components by immunohistochemistry supports those epigenetic mechanisms may be involved in the deregulation of these genes.
- Valemetostat (DS-3201) is an enhancer of zeste homolog 1 and 2 (EZH1/2) dual inhibitor that is actively being investigated in phase I and II trials for hematologic malignancies and is approved for adult T-cell leukemia/lymphoma (ATL) indication in Japan.
- Patients with recurrent or metastatic (R/M) pembrolizumab-na(SqrRoot) ve human papillomavirus (HPV)-negative HNSCC have a low 6-month progression-free survival (PFS) (28%) with pembrolizumab monotherapy, thus novel interventions are needed to increase the efficacy of pembrolizumab.
Objectives:
Phase Ib:
- To determine the recommended phase II dose (RP2D) of valemetostat in combination with pembrolizumab.
- To evaluate the safety of valemetostat in combination with pembrolizumab.
Phase II:
-To determine the disease control rate (DCR)=partial response (PR) + complete response (CR) + stable disease (SD).
Eligibility:
-Participants must have a diagnosis of locoregionally recurrent or metastatic (R/M) HPVnegative (Phase Ib and Phase II) or positive HNSCC (Phase Ib only): oral cavity, tonsil, pharynx, hypopharynx, larynx. Note: Nasopharyngeal carcinoma and cutaneous squamous cell carcinoma (SCC) are excluded
OR
(R/M) squamous non-small cell lung cancer (NSCLC) (Phase Ib only)
OR
(R/M) sinonasal carcinomas of the head and neck (Phase Ib only).
- Age >18 years.
- Adequate organ and marrow function.
Design:
- This is an open-label multicenter phase Ib/II study to evaluate the safety and efficacy of the combined treatment of valemetostat and pembrolizumab.
- During phase Ib we will estimate the RP2D of the valemetostat in combination with pembrolizumab.
- During phase II we will examine the efficacy and continue to evaluate the safety of the study regimen at the RP2D of the valemetostat in combination with pembrolizumab.
- Participants will receive treatment in cycles consisting of 21 (+/- 3) days for 2 years.
- Conditions
- Sinonasal Cancer, Squamous Non-small Cell Lung Cancer, Lung Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcnimona, Head and Neck Cancer
- Being tested
- pembrolizumab, valemetostat
- Keywords
- Pd-L1 Inhibitor, Valemetostat + pembrolizumab, Pembrolizumab, Valemetostat
- Medical subject headings
- Lung Neoplasms, 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.
pembrolizumabDrug
Phase Ib: Pembrolizumab 200mg will be administered by IV infusion every 3 weeks.
Phase II: Pembrolizumab 200mg will be administered by IV infusion every 3 weeks.
valemetostatDrug
Phase Ib: Valemetostat will be given orally every day of every cycle (DL-1: 100mg, DL1: 150mg, DL2: 200mg).
Phase II: Valemetostat will be given orally daily at the recommended phase 2 dose.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Pembrolizumab + de-escalating doses of valemetostat Receives: Drug: pembrolizumab; Drug: valemetostat |
| Arm 2 | Experimental | RP2D of valemetostat in combination with pembrolizumab Receives: Drug: pembrolizumab; Drug: valemetostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Disease control rate (DCR)
Best confirmed response in participants with PD-L1 positive (CPS >=1), HPV-negative relapsing/metatstic HNSCC treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone, by CT scan and brain MRI (PR+CR+SD)
Measured: Study start until progression or 2 years after treatment initiation
Phase Ib: Safety of valemetostat in combination with pembrolizumab
Any toxicities that occur during timeframe.
Measured: Study start-30 days after last dose of study agents
Phase Ib: Recommended phase II dose (RP2D) of valemetostat in combination with pembrolizumab
Number of dose limiting toxicities (DLTs) that occur within the DLT period will determine RP2D.
Measured: 42 days
Secondary outcomes (7)
Pharmacokinetics of valemetostat in combination with pembrolizumab
Valemetostat level in blood samples collected for PK analysis
Measured: Phase Ib: C1D1, C1D8, C1D15, and C2D1Phase II: C0D1, C1D1, C1D8, C1D15, and C2D1
Overall survival (OS) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone
Participants will be assessed for survival while on study therapy and every 9 weeks before progression / every 6 weeks after progression.
Measured: Study start until progression or 2 years after treatment initiation.
6-month progression free survival (PFS) rate in participants treated with valemetostat and pembrolizumab compared to historical controls treated with pembrolizumab alone
Participants will be assessed for survival at 6 months after start of study, or until progression.
Measured: Phase Ib: Study start until progression or 6 months after treatment initiationPhase II: Study start until progression or 6 months after tx initiation
Progression free survival (PFS) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone
Participants will be assessed for survival until progression or 2 years after treatment start.
Measured: Phase Ib: Study start until progression or 2 years after treatment initiationPhase II: Study start until progression or 2 years after treatment initiation
Clinical benefit rate (CBR) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone
Stable disease >= 6 months + complete response + partial response
Measured: Phase 1b: Study start until progression or 2 years after treatment initiation.Phase II: Study start until progression or 2 years after treatment initiation.
Objective response rate (ORR) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone
ORR will be evaluated with periodic CT imaging.
Measured: Phase 1b: Treatment start until progression or 2 years after treatment initiation.Phase II: Treatment start until progression or 2 years after treatment initiation.
Safety of the valemetostat and pembrolizumab combination (Phase II)
Any toxicities identified during evaluation timeframe.
Measured: Treatment start until 30 days after last dose of study agents.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start9 Jul 2025
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Why it stopped: Study was never opened for enrollment as the CRADA was never executed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinonasal CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vassiliki Saloura, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879484
- Sponsor's protocol ID
- 10001545
- Other IDs
- 001545-C
- Status last verified
- Jul 2025
- First submitted
- 26 May 2023
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Multicenter Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS
- ClinicalTrials.gov ID
- NCT05879484
- Acronym / sponsor ID
- 10001545
- Conditions
- Sinonasal Cancer, Squamous Non-small Cell Lung Cancer, Lung Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcnimona, Head and Neck Cancer
- Keywords
- Pd-L1 Inhibitor, Valemetostat + pembrolizumab, Pembrolizumab, Valemetostat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never opened for enrollment as the CRADA was never executed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide. These cancers have different causes, with smoking/tobacco exposure and human papilloma virus infection being the most common. . When HNSCC occurs in people who are not infected with HPV, the cancers are more likely to return after treatment; when this happens, overall survival is only about 10 months, thus better treatments are needed.
Objective:
To test a combination treatment using 2 drugs (valemetostat and pembrolizumab) in people with HNSCC. Phase 1b of the study will determine a recommended dose of the 2 drugs and evaluate how safe the combination is.; this will include patients with HPV-positive and HPV-negative HNSCC, as well as squamous cell NSCLC that have progressed on anti-PD-1/anti-PD-L1 therapies.Phase II will determine how effective the combination is and will focus on patients with HPV-negative HNSCC.
Eligibility:
People aged 18 years and older with HPV-negative HNSCC, sinonasal carcinoma of the head and neck, or squamous non-small cell lung cancer (NSCLC).
Design:
Participants will be screened. They will have a physical exam. They will have blood and urine tests and tests of their heart function. They will have imaging scans. They may have a biopsy: A small sample of tissue will be removed from the tumor.
Treatment will be given in 21-day cycles.
Pembrolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will receive pembrolizumab on the first day of each cycle.
Valemetostat is a tablet taken by mouth. Participants will take the tablet once a day at home. They will record the date and time of each dose in a diary. They will also write down any adverse effects they experience.
Participants may remain in the study up to 2 years.
Detailed description
Background:
- Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide, with approximately 60,000 patients diagnosed annually in the United States.
- Only 14% of HNSCC patients have structural defects in the genes encoding for the human leukocyte antigens (HLA) class I components, while a higher percentage of these tumors show downregulation of HLA class I components by immunohistochemistry supports those epigenetic mechanisms may be involved in the deregulation of these genes.
- Valemetostat (DS-3201) is an enhancer of zeste homolog 1 and 2 (EZH1/2) dual inhibitor that is actively being investigated in phase I and II trials for hematologic malignancies and is approved for adult T-cell leukemia/lymphoma (ATL) indication in Japan.
- Patients with recurrent or metastatic (R/M) pembrolizumab-na(SqrRoot) ve human papillomavirus (HPV)-negative HNSCC have a low 6-month progression-free survival (PFS) (28%) with pembrolizumab monotherapy, thus novel interventions are needed to increase the efficacy of pembrolizumab.
Objectives:
Phase Ib:
- To determine the recommended phase II dose (RP2D) of valemetostat in combination with pembrolizumab.
- To evaluate the safety of valemetostat in combination with pembrolizumab.
Phase II:
-To determine the disease control rate (DCR)=partial response (PR) + complete response (CR) + stable disease (SD).
Eligibility:
-Participants must have a diagnosis of locoregionally recurrent or metastatic (R/M) HPVnegative (Phase Ib and Phase II) or positive HNSCC (Phase Ib only): oral cavity, tonsil, pharynx, hypopharynx, larynx. Note: Nasopharyngeal carcinoma and cutaneous squamous cell carcinoma (SCC) are excluded
OR
(R/M) squamous non-small cell lung cancer (NSCLC) (Phase Ib only)
OR
(R/M) sinonasal carcinomas of the head and neck (Phase Ib only).
- Age >18 years.
- Adequate organ and marrow function.
Design:
- This is an open-label multicenter phase Ib/II study to evaluate the safety and efficacy of the combined treatment of valemetostat and pembrolizumab.
- During phase Ib we will estimate the RP2D of the valemetostat in combination with pembrolizumab.
- During phase II we will examine the efficacy and continue to evaluate the safety of the study regimen at the RP2D of the valemetostat in combination with pembrolizumab.
- Participants will receive treatment in cycles consisting of 21 (+/- 3) days for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: pembrolizumab, Drug: valemetostatPembrolizumab + de-escalating doses of valemetostat |
| Arm 2 | Experimental | Drug: pembrolizumab, Drug: valemetostatRP2D of valemetostat in combination with pembrolizumab |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (27 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to valemetostat or pembrolizumab used in the study.
- Prior curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to the first dose of study drug(s).
- Prior systemic therapy (e.g., chemotherapy, immunomodulatory therapy, monoclonal antibody therapy, or investigational therapy) within 4 weeks, or 5 half-lives of the drug, whichever is longer, prior to the first dose of the study drug(s).
- History of previous treatment with EZH2 inhibition.
- Participants currently receiving any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pembrolizumabPhase Ib: Pembrolizumab 200mg will be administered by IV infusion every 3 weeks. Phase II: Pembrolizumab 200mg will be administered by IV infusion every 3 weeks. | Drug | Arm 1, Arm 2 |
| valemetostatPhase Ib: Valemetostat will be given orally every day of every cycle (DL-1: 100mg, DL1: 150mg, DL2: 200mg). Phase II: Valemetostat will be given orally daily at the recommended phase 2 dose. | Drug | Arm 1, Arm 2 |
Primary outcome
Phase II: Disease control rate (DCR)
Time frame: Study start until progression or 2 years after treatment initiation
Best confirmed response in participants with PD-L1 positive (CPS >=1), HPV-negative relapsing/metatstic HNSCC treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone, by CT scan and brain MRI (PR+CR+SD)
Phase Ib: Safety of valemetostat in combination with pembrolizumab
Time frame: Study start-30 days after last dose of study agents
Any toxicities that occur during timeframe.
Phase Ib: Recommended phase II dose (RP2D) of valemetostat in combination with pembrolizumab
Time frame: 42 days
Number of dose limiting toxicities (DLTs) that occur within the DLT period will determine RP2D.
7 secondary outcomes
Pharmacokinetics of valemetostat in combination with pembrolizumab
Time frame: Phase Ib: C1D1, C1D8, C1D15, and C2D1Phase II: C0D1, C1D1, C1D8, C1D15, and C2D1
Overall survival (OS) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone
Time frame: Study start until progression or 2 years after treatment initiation.
6-month progression free survival (PFS) rate in participants treated with valemetostat and pembrolizumab compared to historical controls treated with pembrolizumab alone
Time frame: Phase Ib: Study start until progression or 6 months after treatment initiationPhase II: Study start until progression or 6 months after tx initiation
Progression free survival (PFS) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone
Time frame: Phase Ib: Study start until progression or 2 years after treatment initiationPhase II: Study start until progression or 2 years after treatment initiation
Clinical benefit rate (CBR) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone
Time frame: Phase 1b: Study start until progression or 2 years after treatment initiation.Phase II: Study start until progression or 2 years after treatment initiation.
Objective response rate (ORR) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone
Time frame: Phase 1b: Treatment start until progression or 2 years after treatment initiation.Phase II: Treatment start until progression or 2 years after treatment initiation.
Safety of the valemetostat and pembrolizumab combination (Phase II)
Time frame: Treatment start until 30 days after last dose of study agents.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vassiliki Saloura, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing pembrolizumab and valemetostat in people with Sinonasal Cancer and Squamous Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) 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 0 inclusion and 27 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: withdrawn, as of the sponsor's last update on 10 Jul 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Phase II: Disease control rate (DCR) (time frame: Study start until progression or 2 years after treatment initiation). 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?
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 10 Jul 2025.