NCT05010629 · STUDY IN CONTEXT
9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma
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
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
PFS based on Kaplan-Meier is defined as the time from registration to the earlier of progressive disease (PD) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
DOR is defined as the time from date of first documented confirmed objective response to date of first documented progressive disease (PD). Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Number of participants with treatment-related AE is defined as the number of participants who experienced at least one AE assessed as possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
UW-QOL Global Question 1 assessed how participants felt relative to before they developed their cancer. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 5-point ordinal scale and transformed to a 0-100 score, where 0 = Much worse, 25 = Somewhat worse, 50 = About the same, 75 = Somewhat better, and 100 = Much better.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Mean Score of Global Question 1 in University of Washington Quality of Life Questionnaire (UW-QOL)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- qol key
- qol-0005
- source section id
- NCT05010629-om-0005
- source outcome index
- 5
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Mean Score of Global Question 1 in University of Washington Quality of Life Questionnaire (UW-QOL)
- measure definition
- UW-QOL Global Question 1 assessed how participants felt relative to before they developed their cancer. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 5-point ordinal scale and transformed to a 0-100 score, where 0 = Much worse, 25 = Somewhat worse, 50 = About the same, 75 = Somewhat better, and 100 = Much better.
- time frame
- Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- trial label
- 9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma
- 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
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0000
- source section id
- NCT05010629-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
- time origin
- Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- According to the protocol, all evaluable patients were combined for the primary analysis.
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0001
- source section id
- NCT05010629-om-0001
- source outcome index
- 1
- endpoint
- Median Progression Free Survival (PFS)
- endpoint definition
- PFS based on Kaplan-Meier is defined as the time from registration to the earlier of progressive disease (PD) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
- time origin
- Tumor assessments were performed every 9 weeks for up to 20.2 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0002
- source section id
- NCT05010629-om-0002
- source outcome index
- 2
- endpoint
- Median Overall Survival (OS)
- endpoint definition
- Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
- time origin
- Up to 38.1 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0003
- source section id
- NCT05010629-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response (DOR)
- endpoint definition
- DOR is defined as the time from date of first documented confirmed objective response to date of first documented progressive disease (PD). Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
- time origin
- Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The analysis dataset is comprised of all participants with measurable disease at baseline who achieved objective response on treatment. No responders among Part I participants.
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0004
- source section id
- NCT05010629-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Treatment Related Adverse Events (AE)
- endpoint definition
- Number of participants with treatment-related AE is defined as the number of participants who experienced at least one AE assessed as possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
- time origin
- AEs were assessed at Day 1 and Day 4 of each 21-day treatment cycle; assessed for up to 16.6 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0005
- source section id
- NCT05010629-om-0005
- source outcome index
- 5
- endpoint
- Mean Score of Global Question 1 in University of Washington Quality of Life Questionnaire (UW-QOL)
- endpoint definition
- UW-QOL Global Question 1 assessed how participants felt relative to before they developed their cancer. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 5-point ordinal scale and transformed to a 0-100 score, where 0 = Much worse, 25 = Somewhat worse, 50 = About the same, 75 = Somewhat better, and 100 = Much better.
- time origin
- Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Evaluable Patients Popupulation
- regimen
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 in participants enrolled in Part II (lead-in therapy). 9-ING-41 twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 9-ING-41 + Carboplatin (Part I)
- regimen
- Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- regimen
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 9-ING-41 + Carboplatin (Part I)
- regimen
- Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- regimen
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- regimen
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0004
- arm key
- OG000
- arm label
- 9-ING-41 + Carboplatin (Part I)
- regimen
- Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- regimen
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0005
- arm key
- OG000
- arm label
- 9-ING-41 + Carboplatin (Part I)
- regimen
- Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- regimen
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05010629-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- harm key
- EG000
- source section id
- NCT05010629-ae
- event group key
- EG000
- event group label
- 9-ING-41 + Carboplatin (Part I)
- serious affected
- 10
- serious at risk
- 16
- other affected
- 16
- other at risk
- 16
- frequency threshold
- 0
- collection period
- Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months.
- event definition
- Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
- undenominated note
- Source null
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- harm key
- EG001
- source section id
- NCT05010629-ae
- event group key
- EG001
- event group label
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- serious affected
- 8
- serious at risk
- 16
- other affected
- 16
- other at risk
- 16
- frequency threshold
- 0
- collection period
- Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months.
- event definition
- Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
- 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-adenoid-cystic-carcinoma
- nct id
- NCT05010629
- qol key
- qol-0005
- source section id
- NCT05010629-om-0005
- source outcome index
- 5
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Mean Score of Global Question 1 in University of Washington Quality of Life Questionnaire (UW-QOL)
- measure definition
- UW-QOL Global Question 1 assessed how participants felt relative to before they developed their cancer. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 5-point ordinal scale and transformed to a 0-100 score, where 0 = Much worse, 25 = Somewhat worse, 50 = About the same, 75 = Somewhat better, and 100 = Much better.
- time frame
- Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point
- 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
Triangle