Recurrent Head and Neck Squamous Cell CarcinomaPhase 2NCT04643379
Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma
A Phase 2 study testing Olaparib, Pembrolizumab and Carboplatin in people with Recurrent Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Squamous Cell Carcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
In this study, patients with recurrent or metastatic head and neck squamous cell carcinoma will receive first line treatment with olaparib, pembrolizumab, and carboplatin. The primary hypothesis is that olaparib, pembrolizumab and carboplatin will result in an overall response rate (ORR) higher than the historical ORR… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Olaparib, Pembrolizumab and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2021to 31 Oct 2028
- 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
- Diagnosis of histologically or cytologically confirmed recurrent or metastatic HNSCC of the oral cavity, oropharynx, larynx, hypopharynx, or p16+ SCC of the neck (unknown primary).
- Measurable disease per RECIST. Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
- Incurable disease, or ineligible for (including patient declined) local therapy.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Life expectancy ≥ 16 weeks.
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- Normal bone marrow and organ function as defined below (specimens must be collected within 10 days prior to the start of study treatment):
- Hemoglobin ≥ 10.0 g/dL (criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 2 weeks)
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- INR or PT ≤ 1.5 x institutional upper limit of normal (IULN) and aPTT ≤ 1.5 x IULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN unless liver metastases are present (in which case they must be ≤ 5 x IULN)
- Serum creatinine <1.5 x ULN or creatinine clearance ≥ 51 mL/min by Cockcroft-Gault or based on a 24-hour urine test
- Known p16 expression, if oropharyngeal primary.
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 72 hours of Day 1 of study treatment:
- Postmenopausal is defined as:
- Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50
- radiation-induced oophorectomy with last menses >1 year ago
- chemotherapy-induced menopause with >1 year interval since last menses
- surgical sterilization (bilateral oophorectomy or hysterectomy)
- Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception (see Section 5.6) if they are of childbearing potential
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Progression within 6 months of curatively intended systemic therapy given for locoregionally advanced disease.
- Investigational therapy within 28 days of treatment start.
- Prior systemic therapy for recurrent or metastatic disease.
- Known CNS metastases/leptomeningeal metastatic disease.
- Other malignancy unless curatively treated with no evidence of disease for ≥ 2 years except: adequately treated non-melanoma skin cancer, curative treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1 grade 1 endometrial carcinoma; or low risk-disease per discretion of the PI.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib, pembrolizumab, carboplatin, or other agents used in the study.
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- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
- Concomitant use of known strong CYP3A inducers (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St. John's wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 ms, electrolyte disturbances, etc.) or patients with congenital long QT syndrome.
- Diagnosis of myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
- Major surgery within 2 weeks of starting study treatment; must have recovered from any effects of major surgery.
- 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 prior to the first dose of treatment.
- Received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of pembrolizumab. Administration of killed vaccines is allowed. Examples of live vaccines is allowed. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.
- Considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Unable to swallow orally administered medication or with gastrointestinal disorder likely to interfere with absorption of study medication.
- Pregnant and/or breastfeeding. A WOCBP who has a positive urine pregnancy test within 72 hours of first dose of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female patients who are expecting to conceive or male patients who are expecting to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Prior organ or allogeneic stem cell transplant or double umbilical cord blood transplantation.
- Has an active autoimmune disease (i.e. rheumatoid arthritis, lupus, Sjogren's syndrome) that has required IV or subcutaneous systemic treatment in the past 2 years (excluding Rituxan). Replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- 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.
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a known history of active TB (Bacillus Tuberculosis).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma: A Single-Arm, Phase 2 Trial
In this study, patients with recurrent or metastatic head and neck squamous cell carcinoma will receive first line treatment with olaparib, pembrolizumab, and carboplatin. The primary hypothesis is that olaparib, pembrolizumab and carboplatin will result in an overall response rate (ORR) higher than the historical ORR observed with pembrolizumab, platinum and 5-FU.
- Conditions
- Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
- Being tested
- Olaparib, Pembrolizumab, Carboplatin, Peripheral blood draw
- 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.
OlaparibDrug
Also called Lynparza
Supplied by Merck \& Co.
PembrolizumabDrug
Also called Keytruda
Supplied by Merck \& Co.
CarboplatinDrug
Commercially available
Peripheral blood drawProcedure or surgery
Baseline (cycle 1 day 1), cycle 2 day 1, and at disease progression
| Study group | Role | What they receive |
|---|---|---|
| Olaparib + Pembrolizumab + Carboplatin AUC | Experimental | -Patients enrolled in this study will receive olaparib, pembrolizumab and carboplatin in three-week cycles for six cycles, followed by maintenance therapy with three-week cycles of olaparib and pembrolizumab. Treatment will continue until disease progression, intolerable toxicity, patient or physician decision to stop therapy, or after 35 cycles, whichever occurs first. Drug dosing for each cycle is as follows:
* Olaparib 200 mg twice per day (bid) by mouth (po) Days 1-10 for the first six cycles (when given with carboplatin), followed by 400 mg bid po Days 1-21 of subsequent cycles.
* Pembrolizumab 200 mg intravenous (IV) Day 1.
* Carboplatin AUC 5 IV on Day 1 for up to six cycles. Receives: Drug: Olaparib; Drug: Pembrolizumab; Drug: Carboplatin; Procedure: Peripheral blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) as Assessed by RECIST v1.1
ORR is defined as the number of participants with complete response (CR) or partial response (PR) per RECIST v1.1.
CR is defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm.
PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Secondary outcomes (13)
Duration of Response (DoR)
DoR is defined as time from date of first response (complete or partial) on CT scans through date of progression or last date of follow-up alive, whichever comes first.
Complete response (CR) is defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm.
Partial response (PR) is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
Measured: Through completion of follow-up (median length of follow-up 33.8 months, IQR=20.5-41.8 months)
Incidence of Adverse Events
Grade 1 to 2 adverse events with an incidence of ≥10% are shown. All grade 3 to 5 events are shown.
Measured: Through 28 days after completion of treatment (median cycles (each cycle is 21 days) of treatment=10, IQR=3-26 cycles)
Correlation of Baseline Tumor HR and PTEN Gene Status With Objective Response Rate (ORR)
Noted as altered (defined as presence of an alteration in one or more HR genes or PTEN) or not altered.
ORR is defined as the number of participants with complete response (CR) or partial response (PR) per RECIST v1.1.
CR is defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm.
PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor PD-L1 CPS Status With Objective Response Rate (ORR)
PD-L1 CPS status includes ≥20 or CPS 0-19.
ORR is defined as the number of participants with complete response (CR) or partial response (PR) per RECIST v1.1.
CR is defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm.
PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HPV (p16) Expression Status With Objective Response Rate (ORR)
Noted as HPV positive or HPV negative.
ORR is defined as the number of participants with complete response (CR) or partial response (PR) per RECIST v1.1.
CR is defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm.
PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HR and PTEN Gene Status With Median Progression Free Survival (PFS)
Noted as altered (defined as presence of an alteration in one or more HR genes or PTEN) or not altered.
PFS is defined as time from study enrollment until the date of progression or death, whichever occurs first.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor PD-L1 CPS Status With Median Progression-free Survival (PFS)
PD-L1 CPS status includes ≥20 or CPS 0-19.
PFS is defined as time from study enrollment until the date of progression or death, whichever occurs first.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HPV (p16) Expression Status With Median Progression-free Survival (PFS)
Noted as HPV positive or HPV negative.
PFS is defined as time from study enrollment until the date of progression or death, whichever occurs first.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HR and PTEN Gene Status With Median Overall Survival (OS)
Noted as altered (defined as presence of an alteration in one or more HR genes or PTEN) or not altered.
OS is defined as the time from the date of first study treatment until death.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor PD-L1 CPS Status With Median Overall Survival (OS)
PD-L1 CPS status includes ≥20 or CPS 0-19.
OS is defined as the time from the date of first study treatment until death.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HPV (p16) Expression Status With Median Overall Survival (OS)
Noted as HPV positive or HPV negative.
OS is defined as the time from the date of first study treatment until death.
Measured: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Progression-free Survival (PFS)
PFS is defined as time from study enrollment until the date of progression or death, whichever occurs first.
Measured: Through completion of follow-up (estimated to be 3 years)
Overall Survival (OS)
OS is defined as the time from the date of first study treatment until death.
Measured: Through completion of follow-up (estimated to be 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start7 Aug 2021
- Primary completion16 Oct 2025
- Study completion31 Oct 2028 (estimated)
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 Recurrent Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Joseph Sanchez Foundation
- Responsible party
- Sponsor
- Investigators
- Douglas Adkins, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643379
- Sponsor's protocol ID
- 202104144
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2020
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma: A Single-Arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04643379
- Acronym / sponsor ID
- 202104144
- Conditions
- Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Joseph Sanchez Foundation
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, patients with recurrent or metastatic head and neck squamous cell carcinoma will receive first line treatment with olaparib, pembrolizumab, and carboplatin. The primary hypothesis is that olaparib, pembrolizumab and carboplatin will result in an overall response rate (ORR) higher than the historical ORR observed with pembrolizumab, platinum and 5-FU.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olaparib + Pembrolizumab + Carboplatin AUC | Experimental | Drug: Olaparib, Drug: Pembrolizumab, Drug: Carboplatin, Procedure: Peripheral blood draw-Patients enrolled in this study will receive olaparib, pembrolizumab and carboplatin in three-week cycles for six cycles, followed by maintenance therapy with three-week cycles of olaparib and pembrolizumab. Treatment will continue until disease progression, intolerable toxicity, patient or physician decision to stop therapy, or after 35 cycles, whichever occurs first. Drug dosing for each cycle is as follows: * Olaparib 200 mg twice per day (bid) by mouth (po) Days 1-10 for the first six cycles (when given with carboplatin), followed by 400 mg bid po Days 1-21 of subsequent cycles. * Pembrolizumab 200 mg intravenous (IV) Day 1. * Carboplatin AUC 5 IV on Day 1 for up to six cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Diagnosis of histologically or cytologically confirmed recurrent or metastatic HNSCC of the oral cavity, oropharynx, larynx, hypopharynx, or p16+ SCC of the neck (unknown primary).
- Measurable disease per RECIST. Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
- Incurable disease, or ineligible for (including patient declined) local therapy.
- At least 18 years of age.
- ECOG performance status ≤ 1
Key exclusion criteria (24 listed)
- Progression within 6 months of curatively intended systemic therapy given for locoregionally advanced disease.
- Investigational therapy within 28 days of treatment start.
- Prior systemic therapy for recurrent or metastatic disease.
- Known CNS metastases/leptomeningeal metastatic disease.
- Other malignancy unless curatively treated with no evidence of disease for ≥ 2 years except: adequately treated non-melanoma skin cancer, curative treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1 grade 1 endometrial carcinoma; or low risk-disease per discretion of the PI.
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 |
|---|---|---|
| OlaparibAlso: LynparzaSupplied by Merck \& Co. | Drug | Olaparib + Pembrolizumab + Carboplatin AUC |
| PembrolizumabAlso: KeytrudaSupplied by Merck \& Co. | Drug | Olaparib + Pembrolizumab + Carboplatin AUC |
| CarboplatinCommercially available | Drug | Olaparib + Pembrolizumab + Carboplatin AUC |
| Peripheral blood drawBaseline (cycle 1 day 1), cycle 2 day 1, and at disease progression | Procedure or surgery | Olaparib + Pembrolizumab + Carboplatin AUC |
Primary outcome
Objective Response Rate (ORR) as Assessed by RECIST v1.1
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
ORR is defined as the number of participants with complete response (CR) or partial response (PR) per RECIST v1.1. CR is defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
13 secondary outcomes
Duration of Response (DoR)
Time frame: Through completion of follow-up (median length of follow-up 33.8 months, IQR=20.5-41.8 months)
Incidence of Adverse Events
Time frame: Through 28 days after completion of treatment (median cycles (each cycle is 21 days) of treatment=10, IQR=3-26 cycles)
Correlation of Baseline Tumor HR and PTEN Gene Status With Objective Response Rate (ORR)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor PD-L1 CPS Status With Objective Response Rate (ORR)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HPV (p16) Expression Status With Objective Response Rate (ORR)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HR and PTEN Gene Status With Median Progression Free Survival (PFS)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor PD-L1 CPS Status With Median Progression-free Survival (PFS)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HPV (p16) Expression Status With Median Progression-free Survival (PFS)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HR and PTEN Gene Status With Median Overall Survival (OS)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor PD-L1 CPS Status With Median Overall Survival (OS)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Correlation of Baseline Tumor HPV (p16) Expression Status With Median Overall Survival (OS)
Time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)
Progression-free Survival (PFS)
Time frame: Through completion of follow-up (estimated to be 3 years)
Overall Survival (OS)
Time frame: Through completion of follow-up (estimated to be 3 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Douglas Adkins, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib, Pembrolizumab and Carboplatin in people with Recurrent Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Squamous Cell Carcinoma, run by Washington University School of Medicine 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 24 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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 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 27 Oct 2026). 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?
Objective Response Rate (ORR) as Assessed by RECIST v1.1 (time frame: Through completion of follow-up (median length of follow-up 24.8 months, IQR=7.0-36.8 months)). 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 27 Oct 2026.