HPV-positive Oropharyngeal Squamous Cell CarcinomaPhase 2NCT07513324
Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
A Phase 2 study testing Pembroluzimab and Observation in people with HPV-positive Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by Dana-Farber Cancer Institute.
Trial summary
The purpose of this study is to assess risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes in participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV-positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Pembroluzimab and Observation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jan 2030
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically or cytologically confirmed, stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. Participants with HPV-associated disease of unknown primary (cT0) are eligible.
- Participants who undergo upfront surgery are permitted to enroll if their post-operative pathology necessitates that they receive adjuvant therapy.
- Participants who undergo upfront induction chemotherapy with platinum-based therapy are eligible if they have less than a complete clinical or radiologic response to induction as judged by the treating investigator(s).
- Participants with locoregionally recurrent disease are eligible if they completed definitive or curative-intent treatment and meet criteria 3.1, 6e below.
- HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following: (a) IHC staining for p16 with ≥70% expression, and/or (b) DNA testing (PCR or ISH) for high-risk subtypes 16, 18, 31, 33, or 35.
- Tumor tissue available for PD-L1 CPS testing.
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- Age 18 years or older at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Intermediate or high-risk HPV+ disease defined by any one of the following:
- TTMV-HPV DNA score >200 at baseline and failure to clear by >95% by week 4-5 of treatment
- undetectable or low (≤200) TTMV-HPV DNA at baseline prior to treatment with clinical or pathologic T3-4 or N2-3 disease
- known HPV subtypes 18, 31, 33, or 35 (but excluding cT1-2N0 participants)
- known N3 disease or fixed neck nodes as judged by the treating investigator(s)
- any stage disease with known detectable TTMV-HPV DNA 6 weeks or onward from completion of definitive or curative-intent therapy without clinical or radiographic disease and with no additional intervening therapy administered.
- Participants should have adequate organ and marrow function to receive adjuvant immunotherapy as outlined below:
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets > 100,000/µL
- Hemoglobin ≥9.0g./dL or ≥5.6 mmol/La
- Creatinine OR Measured or calculated b creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
- Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
- AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- Ability to understand and the willingness to sign a written informed consent document.
- Participants or persons of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of therapy. Note: Contraception requirements should conform with CTFG guidelines. The pembrolizumab standard for use of highly effective contraceptive methods for POCBP is 120 days (5 half-lives) after the last dose. Abstaining from breastfeeding after study intervention is at least 5 half-lives or 120 days.
Who cannot join
- Participants with AJCC 2017 8th edition stage IV (M1, metastatic) disease.
- Pregnant or lactating women.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or another stimulatory or co-inhibitory T-cell receptor treatment.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of pembrolizumab.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days of first pembrolizumab dosing.
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- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Participants with a history of allogeneic tissue/solid organ transplant are excluded.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of uncontrolled human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority. Well-controlled typically includes a CD4+ T-cell count ≥350 cells/mm3 at the time of screening and achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.
- Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease is permitted if chance of recurrence is thought to be low (in discussion with the Sponsor-investigator).
- ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
- a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
- b Creatinine clearance (CrCl) should be calculated per institutional standard.
About this study
The purpose of this study is to assess risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes in participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.
Read the detailed description
This is a phase 2 randomized, open-label clinical trial to evaluate risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes for participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.
Participants will be randomized 2:1 into one of two study arms: Arm 1 Pembroluzimab vs. Arm 2 Observation. Randomization is stratified by NavDx detectability at 6 weeks post curative intent therapy: yes/no.
The U.S. Food and Drug Administration (FDA) has not approved NavDx® as a method for guiding treatment decision-making for human papillomavirus (HPV)-driven oropharyngeal cancers. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab as a treatment option for human papillomavirus (HPV)-driven oropharyngeal cancers.
The research study procedures include screening for eligibility, in-clinic visits, urine tests, questionnaires, tumor assessment by one or more of the following standard assessment tools: X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans, blood tests (including NavDx TTMV-HPV DNA Testing), biobanking, Electrocardiogram (ECG), and tumor tissue biopsy.
It is expected that about 116 people will take part in this research study.
- Being tested
- Pembroluzimab, Observation
- Keywords
- HPV-positive oropharyngeal squamous cell carcinoma, Oropharyngeal 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.
PembroluzimabDrug
Also called Keytruda, MK-3475
monoclonal antibody, single-dose vial via intravenous (through the arm) infusion, per protocol
ObservationOther
Standard of care observation
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Pembroluzimab | Experimental | * Cycle 1 through Cycle 9 (42-day cycles)
* Days 1-378: Predetermined dose of Pembrolizumab once every 6 weeks, up to 9 cycles
* Follow up for up to 2 years Receives: Drug: Pembroluzimab |
| Observation | Active comparator | Cycle 1 through Cycle 9 (42-day cycles) Days 1-378: Standard of care observation Device: NavDx® TTMV-HPV DNA testing (used for risk stratification and treatment assignment) Follow up for up to 2 years Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival at 2 Years (PFS2)
PFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS is defined as the time from the date of randomization to first invasive local, regional, distant progression, invasive second head and neck primary, or death due to any cause. Participants alive without progression are censored at date of last disease evaluation. Progression should be confirmed by biopsy or lymph node removal when feasible, but may also be determined based on clinical or pathologic evidence at the discretion of the treating investigator.
Measured: 2 years
Grade 3 or 4 Adverse Event (AE) Rate
Grade 3 or 4 AE rate is defined as the proportion of participants who experience grade 3 or 4 adverse events during study treatment. AEs are summarized and graded based on CTCAE 5.0.
Measured: Treatment duration is up to 54 weeks, and adverse events will be collected through 30 days following the end of treatment.
Secondary outcomes (3)
Median Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to first invasive local, regional, distant progression, invasive second head and neck primary, or death due to any cause. Participants alive without progression are censored at date of last disease evaluation. Progression should be confirmed by biopsy or lymph node removal when feasible, but may also be determined based on clinical or pathologic evidence at the discretion of the treating investigator.
Measured: Tumor assessments will be performed every 12 weeks (±2 weeks) for up to 2 years following randomization.
Median Overall Survival (OS)
OS based on Kaplan-Meier method is defined as the time from randomization to death due to any cause or censored at date last known alive.
Measured: Survival will be monitored every 12 weeks (±2 weeks) for up to 2 years following randomization.
Median Distant Metastatic-free Survival (DMFS)
DMFS based on Kaplan-Meier method is defined as the time from randomization to the earlier of the first occurrence of distant or metastatic disease, or death due to any cause. Confirmation of distant metastasis should be obtained via pathologic evaluation (biopsy or lymph node removal) when feasible, by imaging evidence (CT, MRI, or PET-CT) using RECIST-style lesion measurement criteria, or by clinical judgment if pathologic or imaging confirmation is not possible. Progression limited to the primary site or regional lymph nodes is not considered an event for DMFS. Suspicion of distant metastasis based solely on indeterminate or positive PET-CT findings should be confirmed with continued clinical follow-up or pathologically.Participants alive without distant or metastatic recurrence are censored at date of last disease evaluation.
Measured: Tumor assessments will be performed every 12 weeks (±2 weeks) for up to 2 years following randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Why it stopped: study halted prematurely prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-positive Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Michael J. Dennis, MD, Dana-Farber Cancer Institute
- Investigators
- Michael Dennis, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513324
- Sponsor's protocol ID
- 25-742
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
- ClinicalTrials.gov ID
- NCT07513324
- Acronym / sponsor ID
- 25-742
- Keywords
- HPV-positive oropharyngeal squamous cell carcinoma, Oropharyngeal squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study halted prematurely prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 7 Apr 2026 (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.
The purpose of this study is to assess risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes in participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.
Detailed description
This is a phase 2 randomized, open-label clinical trial to evaluate risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes for participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.
Participants will be randomized 2:1 into one of two study arms: Arm 1 Pembroluzimab vs. Arm 2 Observation. Randomization is stratified by NavDx detectability at 6 weeks post curative intent therapy: yes/no.
The U.S. Food and Drug Administration (FDA) has not approved NavDx® as a method for guiding treatment decision-making for human papillomavirus (HPV)-driven oropharyngeal cancers. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab as a treatment option for human papillomavirus (HPV)-driven oropharyngeal cancers.
The research study procedures include screening for eligibility, in-clinic visits, urine tests, questionnaires, tumor assessment by one or more of the following standard assessment tools: X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans, blood tests (including NavDx TTMV-HPV DNA Testing), biobanking, Electrocardiogram (ECG), and tumor tissue biopsy.
It is expected that about 116 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Pembroluzimab | Experimental | Drug: Pembroluzimab* Cycle 1 through Cycle 9 (42-day cycles) * Days 1-378: Predetermined dose of Pembrolizumab once every 6 weeks, up to 9 cycles * Follow up for up to 2 years |
| Observation | Active comparator | Other: ObservationCycle 1 through Cycle 9 (42-day cycles) Days 1-378: Standard of care observation Device: NavDx® TTMV-HPV DNA testing (used for risk stratification and treatment assignment) Follow up for up to 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Participants must have histologically or cytologically confirmed, stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. Participants with HPV-associated disease of unknown primary (cT0) are eligible.
- HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following: (a) IHC staining for p16 with ≥70% expression, and/or (b) DNA testing (PCR or ISH) for high-risk subtypes 16, 18, 31, 33, or 35.
- Tumor tissue available for PD-L1 CPS testing.
- Age 18 years or older at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Key exclusion criteria (15 listed)
- Participants with AJCC 2017 8th edition stage IV (M1, metastatic) disease.
- Pregnant or lactating women.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or another stimulatory or co-inhibitory T-cell receptor treatment.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of pembrolizumab.
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 |
|---|---|---|
| PembroluzimabAlso: Keytruda, MK-3475monoclonal antibody, single-dose vial via intravenous (through the arm) infusion, per protocol | Drug | Adjuvant Pembroluzimab |
| ObservationStandard of care observation | Other | Observation |
Primary outcome
Progression-free Survival at 2 Years (PFS2)
Time frame: 2 years
PFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS is defined as the time from the date of randomization to first invasive local, regional, distant progression, invasive second head and neck primary, or death due to any cause. Participants alive without progression are censored at date of last disease evaluation. Progression should be confirmed by biopsy or lymph node removal when feasible, but may also be determined based on clinical or pathologic evidence at the discretion of the treating investigator.
Grade 3 or 4 Adverse Event (AE) Rate
Time frame: Treatment duration is up to 54 weeks, and adverse events will be collected through 30 days following the end of treatment.
Grade 3 or 4 AE rate is defined as the proportion of participants who experience grade 3 or 4 adverse events during study treatment. AEs are summarized and graded based on CTCAE 5.0.
3 secondary outcomes
Median Progression-free Survival (PFS)
Time frame: Tumor assessments will be performed every 12 weeks (±2 weeks) for up to 2 years following randomization.
Median Overall Survival (OS)
Time frame: Survival will be monitored every 12 weeks (±2 weeks) for up to 2 years following randomization.
Median Distant Metastatic-free Survival (DMFS)
Time frame: Tumor assessments will be performed every 12 weeks (±2 weeks) for up to 2 years following randomization.
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 8 Oct 2026.
- Individual participant dataSharing planned: Yes. The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Michael Dennis, MD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembroluzimab and Observation in people with HPV-positive Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by Dana-Farber Cancer Institute.
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 24 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: withdrawn, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Progression-free Survival at 2 Years (PFS2) (time frame: 2 years). 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?
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 8 Oct 2026.