Squamous Cell Carcinoma of Head and NeckPhase 2NCT04633278
CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing CMP-001 and Pembrolizumab in people with Squamous Cell Carcinoma of Head and Neck, run by Regeneron Pharmaceuticals at 19 sites in United States.
Trial summary
CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- CMP-001 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 19 sitesUnited States
- Study dates
- 21 Jan 2021to 19 Jan 2024
- Phase
- Phase 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
- Histologically- or cytologically-confirmed recurrent or metastatic HNSCC considered incurable by local therapies.
- No prior systemic therapy in the recurrent or metastatic setting. Systemic therapy as part of multi-modal treatment for locally advanced disease is allowed.
- Primary tumor locations of oropharynx, oral cavity, hypopharynx, larynx or paranasal sinus. Participants may not have a primary tumor site of nasopharynx (any histology).
- Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable.
- Combined Positive Score (CPS) ≥ 1 for PD-L1 on Immunohistochemistry (IHC) of tumor tissue.
- Have results of tumor HPV p16 by IHC for oropharyngeal cancer.
Show all 15Show fewer
- Measurable disease as defined by RECIST v1.1, and both of the following:
- At least 1 lesion amenable to repeated Intratumoral (IT) injection.
- Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion.
- Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study drug on Week 1 Day 1 (W1D1) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening.
- Capable of understanding and complying with protocol requirements.
- Women of childbearing potential must have negative serum pregnancy test during Screening and be willing to use an adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug.
- Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug.
- Able and willing to provide written informed consent and to follow study instructions.
- Subjects unable to provide written informed consent on their own behalf will not be eligible for the study.
Who cannot join
- Disease suitable for local therapy administered with curative intent.
- Has PD within 3 months of completion of curatively intent systemic treatment for locoregionally advanced HNSCC.
- Radiation therapy (or other non-systemic therapy) within 2 weeks before the first dose of study drug on W1D1.
- Received prior therapy with PD-1 or PD-L1 blocking antibody therapy in the recurrent/ metastatic setting. If PD-1 or PD-L1 blocking antibody therapy was given as part of curative intent therapy, it must be at least 1 year since receipt of PD-1 or PD-L1 blocking antibody.
- Not fully recovered from adverse events (to Grade 1 or less [per CTCAE v5.0]), with the exception of persistent alopecia, neuropathy, ototoxicity, hypothyroidism, pain, or dysphagia, due to prior treatment.
- Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study drug on W1D1.
Show all 26Show fewer
- Subjects who are currently receiving steroids at a prednisone-equivalent dose of ≤ 10 mg/day do not need to discontinue steroids prior to enrollment.
- Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
- Active pneumonitis, history of noninfectious pneumonitis that required steroids, or history of interstitial lung disease.
- Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, implanted or continuous use of a pacemaker or defibrillator.
- Known history of immunodeficiency.
- Known additional malignancy that is progressing or required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, and thyroid cancer (except anaplastic).
- Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment
- Untreated, symptomatic, or enlarging central nervous system (CNS) metastases or carcinomatous meningitis.
- Prior allogenic tissue/solid organ transplant.
- Active infection requiring systemic therapy.
- Known or suspected active infection with SARS-CoV-2 virus.
- Known or suspected infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus; testing is not required unless suspected.
- Received a live virus vaccination within 30 days before the start of study drug dosing on W1D1.
- Received blood products (including platelets or red blood cells) or colony stimulating factors [including granulocyte colony-stimulating factor (GCSF), granulocyte-macrophage colony-stimulating factor (GMCSF) (or recombinant erythropoietin)] within 30 days before the start of Screening.
- Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.
- Participation in another clinical trial of an investigational anticancer therapy or device within 30 days before the first dose of study drug.
- Requires prohibited treatment (ie. non-protocol specified anticancer pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor).
- Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator.
- Received previous CMP-001 treatment.
- Pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, from the time of consent until at least 120 days after the last dose of study drug.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University Cancer & Blood Center
Athens, Georgia, 30607
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Chicago Medical Center
Chicago, Illinois, 60637
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Bon Secours St. Francis Cancer Center
Greenville, South Carolina, 29607
Houston Methodist Hospital/Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of Tennessee
Knoxville, Tennessee, 37920
University of California - San Diego
La Jolla, California, 92093
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Hematology-Oncology
Los Angeles, California, 90095
Atlantic Health
Morristown, New Jersey, 07960
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Southern California: Norris Oncology/Hematology - Newport Beach
Newport Beach, California, 92663
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Multicenter, Phase 2, Open-label Study of Intratumoral CMP-001 in Combination With Intravenous Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody.
The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC)
Read more
The secondary objectives are to:
- To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC
- To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC
- To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab
Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.
Read the detailed description
Former Sponsor Checkmate Pharmaceuticals
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- CMP-001, Pembrolizumab
- Keywords
- Head and Neck Cancer, Pembrolizumab, Carcinoma, HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMP-001Drug
Also called vidutolimod
Subjects will receive CMP-001 10mg weekly for 2 doses after which CMP-001 will be administered every 3 weeks. The first dose of CMP-001 may be administered subcutaneously (SC) or Intratumorally (IT) at the discretion of Investigator. All subsequent doses will be injected intratumorally every 3 weeks (Q3W).
PembrolizumabDrug
Also called Keytruda
Pembrolizumab 200 mg IV is administered Q3W.
| Study group | Role | What they receive |
|---|---|---|
| CMP-001 and Pembrolizumab | Experimental | All subjects will receive CMP-001 IT and pembrolizumab IV according to the treatment schedule until a reason for treatment discontinuation is reached. Receives: Drug: CMP-001; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR)
Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA).
Measured: Up to approximately 109 weeks
Secondary outcomes (14)
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
TEAE is defined as an AE that started or worsened in severity on or after the date that study drug was first administered (W1D1) until 30 days after the last dose of study treatment.
Measured: Up to approximately 109 weeks
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
NI CTCAE Adverse Event Grades:
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event
Measured: Up to approximately 109 weeks
Duration of Response (DOR)
DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA).
Measured: Up to approximately 28 months (120 weeks)
Duration of Progression-free Survival (PFS)
Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first.
Measured: Up to approximately 28 months (120 weeks)
Duration of Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose date of the study treatment to the date of death from any cause.
Measured: From first dose up to approximately 28 months (120 weeks)
Immune Objective Response Rate (iORR)
Immune objective response rate (iORR), defined as the percentage of participants who have an immune best overall response (iBOR) of immune complete response (iCR) or immune partial response (iPR) based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) as determined by Investigator.
Measured: Up to approximately 109 weeks
Immune Progression-free Survival (iPFS)
iPFS, defined as the time from date of first dose of study drug to date of immune Confirmed Progressive Disease (iCPD) based on immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by IA or death, whichever occurs first.
Measured: Up to approximately 28 months (120 weeks)
Confirmed ORR Based on Human Papillomavirus (HPV) Status
Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA) based on HPV status.
Measured: Up to approximately 109 weeks
Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions
Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA) based on PD-L1 expressions (combined positive score [CPS] ≥ 1 and CPS ≥ 20)
Measured: Up to approximately 109 weeks
Duration of PFS Based on HPV Status
Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. PFS based on HPV status
Measured: Up to approximately 28 months (120 weeks)
Immune Duration of Response (iDOR)
iDOR, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) by IA.
Measured: Up to approximately 28 months (120 weeks)
DOR Based on HPV Status
DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA). DOR based on HPV status.
Measured: Up to approximately 28 months (120 weeks)
DOR Based on PD-L1 Expressions
DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA). DOR based on PD-L1 expressions (combined positive score [CPS] 20).
Measured: Up to approximately 28 months (120 weeks)
PFS Based on PD-L1 Expressions
Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. PFS based on PD-L1 expressions (combined positive score [CPS] 20).
Measured: Up to approximately 28 months (120 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start21 Jan 2021
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633278
- Sponsor's protocol ID
- CMP-001-007
- Status last verified
- May 2025
- First submitted
- 26 Oct 2020
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2, Open-label Study of Intratumoral CMP-001 in Combination With Intravenous Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04633278
- Acronym / sponsor ID
- CMP-001-007
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Head and Neck Cancer, Pembrolizumab, Carcinoma, HNSCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody.
The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC)
The secondary objectives are to:
- To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC
- To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC
- To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab
Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.
Detailed description
Former Sponsor Checkmate Pharmaceuticals
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMP-001 and Pembrolizumab | Experimental | Drug: CMP-001, Drug: PembrolizumabAll subjects will receive CMP-001 IT and pembrolizumab IV according to the treatment schedule until a reason for treatment discontinuation is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically- or cytologically-confirmed recurrent or metastatic HNSCC considered incurable by local therapies.
- No prior systemic therapy in the recurrent or metastatic setting. Systemic therapy as part of multi-modal treatment for locally advanced disease is allowed.
- Primary tumor locations of oropharynx, oral cavity, hypopharynx, larynx or paranasal sinus. Participants may not have a primary tumor site of nasopharynx (any histology).
- Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable.
- Combined Positive Score (CPS) ≥ 1 for PD-L1 on Immunohistochemistry (IHC) of tumor tissue.
Key exclusion criteria (26 listed)
- Disease suitable for local therapy administered with curative intent.
- Has PD within 3 months of completion of curatively intent systemic treatment for locoregionally advanced HNSCC.
- Radiation therapy (or other non-systemic therapy) within 2 weeks before the first dose of study drug on W1D1.
- Received prior therapy with PD-1 or PD-L1 blocking antibody therapy in the recurrent/ metastatic setting. If PD-1 or PD-L1 blocking antibody therapy was given as part of curative intent therapy, it must be at least 1 year since receipt of PD-1 or PD-L1 blocking antibody.
- Not fully recovered from adverse events (to Grade 1 or less [per CTCAE v5.0]), with the exception of persistent alopecia, neuropathy, ototoxicity, hypothyroidism, pain, or dysphagia, due to prior treatment.
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 |
|---|---|---|
| CMP-001Also: vidutolimodSubjects will receive CMP-001 10mg weekly for 2 doses after which CMP-001 will be administered every 3 weeks. The first dose of CMP-001 may be administered subcutaneously (SC) or Intratumorally (IT) at the discretion of Investigator. All subsequent doses will be injected intratumorally every 3 weeks (Q3W). | Drug | CMP-001 and Pembrolizumab |
| PembrolizumabAlso: KeytrudaPembrolizumab 200 mg IV is administered Q3W. | Drug | CMP-001 and Pembrolizumab |
Primary outcome
Confirmed Objective Response Rate (ORR)
Time frame: Up to approximately 109 weeks
Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA).
14 secondary outcomes
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Time frame: Up to approximately 109 weeks
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
Time frame: Up to approximately 109 weeks
Duration of Response (DOR)
Time frame: Up to approximately 28 months (120 weeks)
Duration of Progression-free Survival (PFS)
Time frame: Up to approximately 28 months (120 weeks)
Duration of Overall Survival (OS)
Time frame: From first dose up to approximately 28 months (120 weeks)
Immune Objective Response Rate (iORR)
Time frame: Up to approximately 109 weeks
Immune Progression-free Survival (iPFS)
Time frame: Up to approximately 28 months (120 weeks)
Confirmed ORR Based on Human Papillomavirus (HPV) Status
Time frame: Up to approximately 109 weeks
Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions
Time frame: Up to approximately 109 weeks
Duration of PFS Based on HPV Status
Time frame: Up to approximately 28 months (120 weeks)
Immune Duration of Response (iDOR)
Time frame: Up to approximately 28 months (120 weeks)
DOR Based on HPV Status
Time frame: Up to approximately 28 months (120 weeks)
DOR Based on PD-L1 Expressions
Time frame: Up to approximately 28 months (120 weeks)
PFS Based on PD-L1 Expressions
Time frame: Up to approximately 28 months (120 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Summary is available on TrialSummaries.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Related trials for Squamous Cell Carcinoma of Head and Neck
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMP-001 and Pembrolizumab in people with Squamous Cell Carcinoma of Head and Neck, run by Regeneron Pharmaceuticals at 19 sites 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 15 inclusion and 26 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 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 phase mean?
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 8 Apr 2025). 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?
Confirmed Objective Response Rate (ORR) (time frame: Up to approximately 109 weeks). 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 11 May 2025.