TriangleNCT04576091 · STUDY IN CONTEXT
Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Dose of elimusertib (BAY 1895344) and concurrent stereotactic (8 Gy x 3 RT) body radiation therapy. Two 3-week cycles of therapy.
Number of patients who experienced Dose Limiting Toxicities. DLTs are defined as occurrence of any of the following events, if judged by the Investigator to be possibly, probably or definitely related to study drug administration 1. Any Grade 4 or greater adverse event per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0) observed within 90 days of the last dose of radiation therapy. 2. Grade 3 nonhematologic toxicity (not laboratory) lasting \>5 days despite optimal supportive care. 3. Any Grade 3 nonhematologic laboratory value if: • Medical intervention is required to treat the patient, or • The abnormality leads to hospitalization, or • The abnormality persists for \>1 week. 4. Febrile neutropenia. 5. Thrombocytopenia \<25000/mm3 if associated with bleeding requiring intervention. 6. Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity.
Dose of elimusertib (BAY 1895344) and concurrent stereotactic (8 Gy x 3 RT) body radiation therapy. Two 3-week cycles of therapy.
Number of patients that experienced Adverse Events and/or Serious Adverse Events assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 5, at least possibly related to treatment.
Number of patients that experienced AEs and/or SAEs per CTCAE version 5 at least possibly related to treatment.
A competing risk analysis will be conducted with local failure, distal failure, and death as competing events. The cumulative incidence and 95% confidence interval for local failure will be estimated. Time to each event will be measured from the start of treatment regimen (day 1 pembrolizumab).
Reported safety
Quality of life and patient-reported measures
FACT · Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- qol key
- qol-0013
- source section id
- NCT04576091-om-0013
- source outcome index
- 13
- instrument
- FACT
- instrument basis
- matched 'fact-h' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- measure definition
- The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
- time frame
- At Baseline prior to start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Enrolled patients who complete assessment at indicated timepoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- qol key
- qol-0014
- source section id
- NCT04576091-om-0014
- source outcome index
- 14
- instrument
- FACT
- instrument basis
- matched 'fact-h' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- measure definition
- The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
- time frame
- At 3 months from start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Enrolled patients who complete assessment at indicated timepoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- qol key
- qol-0015
- source section id
- NCT04576091-om-0015
- source outcome index
- 15
- instrument
- FACT
- instrument basis
- matched 'fact-h' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- measure definition
- The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
- time frame
- At 6 months from start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Enrolled patients who complete assessment at indicated timepoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- qol key
- qol-0016
- source section id
- NCT04576091-om-0016
- source outcome index
- 16
- instrument
- FACT
- instrument basis
- matched 'fact-h' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- measure definition
- The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
- time frame
- At 12 months from start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Enrolled patients who complete assessment at indicated timepoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- trial label
- Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 4
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0000
- source section id
- NCT04576091-om-0000
- source outcome index
- 0
- endpoint
- Maximum-tolerated Dose (MTD) (Escalation)
- endpoint definition
- Dose of elimusertib (BAY 1895344) and concurrent stereotactic (8 Gy x 3 RT) body radiation therapy. Two 3-week cycles of therapy.
- time origin
- Up to 6 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0001
- source section id
- NCT04576091-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Dose Limiting Toxicities (DLT)
- endpoint definition
- Number of patients who experienced Dose Limiting Toxicities. DLTs are defined as occurrence of any of the following events, if judged by the Investigator to be possibly, probably or definitely related to study drug administration 1. Any Grade 4 or greater adverse event per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0) observed within 90 days of the last dose of radiation therapy. 2. Grade 3 nonhematologic toxicity (not laboratory) lasting \>5 days despite optimal supportive care. 3. Any Grade 3 nonhematologic laboratory value if: • Medical intervention is required to treat the patient, or • The abnormality leads to hospitalization, or • The abnormality persists for \>1 week. 4. Febrile neutropenia. 5. Thrombocytopenia \<25000/mm3 if associated with bleeding requiring intervention. 6. Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity.
- time origin
- Within 90 days of treatment initiation
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled patients were treated at the lowest dose level.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0002
- source section id
- NCT04576091-om-0002
- source outcome index
- 2
- endpoint
- Dose of BAY 1895344
- endpoint definition
- Dose of elimusertib (BAY 1895344) and concurrent stereotactic (8 Gy x 3 RT) body radiation therapy. Two 3-week cycles of therapy.
- time origin
- Up to 6 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0003
- source section id
- NCT04576091-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Late Adverse Events
- endpoint definition
- Number of patients that experienced Adverse Events and/or Serious Adverse Events assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 5, at least possibly related to treatment.
- time origin
- After 90 days post discontinuation of treatment, up to 1 year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0004
- source section id
- NCT04576091-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Adverse Events
- endpoint definition
- Number of patients that experienced AEs and/or SAEs per CTCAE version 5 at least possibly related to treatment.
- time origin
- Up to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0005
- source section id
- NCT04576091-om-0005
- source outcome index
- 5
- endpoint
- Locoregional Control
- endpoint definition
- A competing risk analysis will be conducted with local failure, distal failure, and death as competing events. The cumulative incidence and 95% confidence interval for local failure will be estimated. Time to each event will be measured from the start of treatment regimen (day 1 pembrolizumab).
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treated patients who were radiologically evaluable.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab, BAY 1895344, SBRT)
- regimen
- Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04576091-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab, BAY 1895344, SBRT)
- regimen
- Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04576091-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab, BAY 1895344, SBRT)
- regimen
- Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04576091-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab, BAY 1895344, SBRT)
- regimen
- Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04576091-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab, BAY 1895344, SBRT)
- regimen
- Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04576091-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab, BAY 1895344, SBRT)
- regimen
- Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04576091-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- harm key
- EG000
- source section id
- NCT04576091-ae
- event group key
- EG000
- event group label
- Treatment (Pembrolizumab, BAY 1895344, SBRT)
- serious affected
- 2
- serious at risk
- 6
- other affected
- 5
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0) up to 29 months for the cohort. All-Cause Mortality monitored up to 36 months for cohort.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- qol key
- qol-0013
- source section id
- NCT04576091-om-0013
- source outcome index
- 13
- instrument
- FACT
- instrument basis
- matched 'fact-h' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- measure definition
- The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
- time frame
- At Baseline prior to start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Enrolled patients who complete assessment at indicated timepoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- qol key
- qol-0014
- source section id
- NCT04576091-om-0014
- source outcome index
- 14
- instrument
- FACT
- instrument basis
- matched 'fact-h' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- measure definition
- The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
- time frame
- At 3 months from start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Enrolled patients who complete assessment at indicated timepoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- qol key
- qol-0015
- source section id
- NCT04576091-om-0015
- source outcome index
- 15
- instrument
- FACT
- instrument basis
- matched 'fact-h' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- measure definition
- The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
- time frame
- At 6 months from start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Enrolled patients who complete assessment at indicated timepoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT04576091
- qol key
- qol-0016
- source section id
- NCT04576091-om-0016
- source outcome index
- 16
- instrument
- FACT
- instrument basis
- matched 'fact-h' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
- measure definition
- The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
- time frame
- At 12 months from start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Enrolled patients who complete assessment at indicated timepoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice