Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 3:39 AM
Study NCT ID:
NCT04193293
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2019-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586691', 'term': 'duvelisib'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'C000711728', 'term': 'spartalizumab'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bgregory@securabio.com', 'phone': '1-702-254-0011', 'title': 'Beth Gregory, PharmD, MBA', 'organization': 'Secura Bio, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was terminated early by the Sponsor due to low enrollment. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}}, 'adverseEventsModule': {'timeFrame': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.', 'description': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Dose-limiting Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': '4 weeks or 28 days', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': '6 months', 'description': 'Number of participants with TEAEs as assessed by the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) as a measure of safety and tolerability of duvelisib in combination with pembrolizumab.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'PRIMARY', 'title': 'Stage 1 and 2: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': 'Up to 2 years', 'description': 'Proportion of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1).', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Stage 1: ORR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': 'Until documented progressive disease (PD), unacceptable toxicity, discontinuation criteria are met, withdrawal, or death (up to 2 years)', 'description': 'Proportion of participants achieving complete CR or PR according to RECIST v 1.1.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and 2: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': 'From first response until documented PD (up to 2 years)', 'description': 'Time from response ≥ PR to documented disease progression according to RECIST v 1.1.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and 2: Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': 'From start of treatment until documented PD or death (up to 2.5 years)', 'description': 'Time from start of treatment to documented disease progression according to RECIST v 1.1, or death due to any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and 2: Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': 'From start of treatment until death (up to 2.5 years)', 'description': 'Time from start of treatment to death.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and 2: Maximum Observed Concentration [Cmax]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': 'Up to 5 cycles (46 weeks)', 'description': 'Pharmacokinetics (PK) parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and Population PK (POPPK) modeling.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and 2: Area Under the Curve [AUC]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': 'Up to 5 cycles (46 weeks)', 'description': 'PK parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and POPPK modeling.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and 2: Number of Participants With TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'timeFrame': '24 months', 'description': 'Number of participants with TEAEs as assessed by CTCAE v5.0.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib twice daily (BID) for 1 week followed by combination therapy with duvelisib BID + pembrolizumab every 3 weeks (q3w) (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study was terminated by the Sponsor due to low enrollment. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.'}], 'measures': [{'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}]}], 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-17', 'size': 2316845, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-27T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'The study was terminated due to low enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2019-12-04', 'resultsFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2019-12-06', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-14', 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage 1: Number of Participants With Dose-limiting Toxicities', 'timeFrame': '4 weeks or 28 days'}, {'measure': 'Stage 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': '6 months', 'description': 'Number of participants with TEAEs as assessed by the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) as a measure of safety and tolerability of duvelisib in combination with pembrolizumab.'}, {'measure': 'Stage 1 and 2: Overall Response Rate (ORR)', 'timeFrame': 'Up to 2 years', 'description': 'Proportion of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1).'}], 'secondaryOutcomes': [{'measure': 'Stage 1: ORR', 'timeFrame': 'Until documented progressive disease (PD), unacceptable toxicity, discontinuation criteria are met, withdrawal, or death (up to 2 years)', 'description': 'Proportion of participants achieving complete CR or PR according to RECIST v 1.1.'}, {'measure': 'Stage 1 and 2: Duration of Response (DOR)', 'timeFrame': 'From first response until documented PD (up to 2 years)', 'description': 'Time from response ≥ PR to documented disease progression according to RECIST v 1.1.'}, {'measure': 'Stage 1 and 2: Progression-free Survival (PFS)', 'timeFrame': 'From start of treatment until documented PD or death (up to 2.5 years)', 'description': 'Time from start of treatment to documented disease progression according to RECIST v 1.1, or death due to any cause.'}, {'measure': 'Stage 1 and 2: Overall Survival', 'timeFrame': 'From start of treatment until death (up to 2.5 years)', 'description': 'Time from start of treatment to death.'}, {'measure': 'Stage 1 and 2: Maximum Observed Concentration [Cmax]', 'timeFrame': 'Up to 5 cycles (46 weeks)', 'description': 'Pharmacokinetics (PK) parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and Population PK (POPPK) modeling.'}, {'measure': 'Stage 1 and 2: Area Under the Curve [AUC]', 'timeFrame': 'Up to 5 cycles (46 weeks)', 'description': 'PK parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and POPPK modeling.'}, {'measure': 'Stage 1 and 2: Number of Participants With TEAEs', 'timeFrame': '24 months', 'description': 'Number of participants with TEAEs as assessed by CTCAE v5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Squamous Cell Carcinoma of the Head and Neck', 'Head and Neck Cancer', 'PI3K-δ,γ', 'PI3K Inhibitor'], 'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study was designed to assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).', 'detailedDescription': 'This was a non-randomized, open-label Phase 1b/2 study designed to evaluate safety, tolerability, and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with R/M HNSCC who were eligible for pembrolizumab monotherapy based on the current pembrolizumab prescribing information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Eastern Cooperative Oncology Group performance status ≤ 1\n* Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx that was considered incurable by local therapies\n* Eligible for pembrolizumab monotherapy based on the current prescribing information for pembrolizumab (Keytruda 2019)\n* Must have had 0 to 2 prior therapies for R/M HNSCC\n* At least 1 measurable lesion (which has not been previously irradiated) according to Response Evaluation Criteria in Solid Tumors version 1.1\n* For stage 1 only: Must have had at least 1 other lesion that could be biopsied and willing to undergo a pretreatment and on-treatment biopsy of the available tumor lesion\n* For stage 1 only: Must have been willing to undergo a pretreatment and on-treatment biopsy of the available tumor lesion\n* Adequate organ function defined by the following laboratory parameters:\n\n * Absolute neutrophil count ≥ 1.5 × 10\\^9/liter (L)\n * Platelet count ≥ 100 × 10\\^9/L\n * Hemoglobin level ≥ 9.0 grams/deciliter (dL)\n * A serum creatinine level \\< 1.5 milligrams/dL, or\n * Estimated creatinine clearance value ≥ 60 milliliters/minute (as determined by the Cockcroft-Gault method) for participants with creatinine levels \\> 1.5 × institutional upper limit of normal (ULN)\n * Total bilirubin level ≤ 1.5 × ULN (exception: participants with Gilbert's Syndrome may have a bilirubin level \\> 1.5 × ULN)\n * Aspartate aminotransaminase/serum glutamic-oxaloacetic transaminase and alanine aminotransferase/serum pyruvic transaminase levels ≤ 2.5 × ULN or ≤ 5 × ULN in participants with liver metastases\n* International normalized ratio or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, unless participant was receiving anticoagulant therapy in which case PT or aPTT must have been within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria\n\n* Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease\n* Received anticancer treatment, major surgery, or any investigational drug within 30 days or 5 half-lives, whichever is shorter, before the start of study intervention\n* Received radiation therapy within 14 days before the start of study intervention, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation; Palliative radiation is allowed if \\> 7 days and any toxicity is ≤ Grade 1\n* Previous treatment with a PI3K, PD-1 or programmed cell death ligand 1 inhibitor\n* Have received organ or allogenic bone marrow or peripheral blood stem cell transplant\n* History of drug-induced colitis or drug-induced pneumonitis; history or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function; tuberculosis treatment within 2 years prior to the start of study intervention; chronic liver disease or veno-occlusive disease/sinusoidal obstruction syndrome\n* Active cytomegalovirus or Epstein-Barr virus infection; history of or known human immunodeficiency virus infection\n* Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection\n* Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening\n* Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A. No prior use within 2 weeks before the start of study intervention Received a live or live attenuated vaccine within 6 weeks of first dose of duvelisib\n* Unable to receive prophylactic treatment for pneumocystis, HSV, or VZV at screening\n* Any active gastrointestinal dysfunction interfering with the participant's ability to be administered oral medications\n* Known active central nervous system metastases and/or carcinomatous meningitis\n* QT interval \\> 500 milliseconds (except for participants with a right or left bundle branch block)\n* New York Heart Association Class III or IV congestive heart failure"}, 'identificationModule': {'nctId': 'NCT04193293', 'briefTitle': 'A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'SecuraBio'}, 'officialTitle': 'A Phase 1b/2 Study of Duvelisib in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Cancer', 'orgStudyIdInfo': {'id': 'VS-0145-130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duvelisib + Pembrolizumab', 'description': 'Stage 1: Duvelisib twice daily (BID) for 1 week followed by combination therapy with duvelisib BID + pembrolizumab every 3 weeks (q3w) (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).\n\nStage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.', 'interventionNames': ['Drug: Duvelisib', 'Biological: Pembrolizumab']}], 'interventions': [{'name': 'Duvelisib', 'type': 'DRUG', 'otherNames': ['VS-0145', 'Copiktra'], 'description': 'Phosphoinositide 3-kinase (PI3K) Inhibitor', 'armGroupLabels': ['Duvelisib + Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['PD-1 inhibitor', 'anti-PD-1', 'Keytruda'], 'description': 'Immunotherapy (programmed cell death protein 1 \\[PD-1\\] inhibitor)', 'armGroupLabels': ['Duvelisib + Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SecuraBio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}