TriangleNCT04895735 · STUDY IN CONTEXT
MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland 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
Assessed by immunohistochemistry. Will investigate correlation with enhanced response to pemetrexed. The associations of these markers with response will be done via Chi-square or Fisher's exact tests by cohort for categorical biomarkers and done via 2-sample t-tests (or the Wilcoxon Rank-Sum test) by cohort for continuous biomarker data. Descriptive statistics and tables will be reported.
Evaluated by Response Evaluation Criteria in Solid Tumors version 1.1.
CBR will be defined as the rate of patients with stable disease, partial response or complete response as their best response during treatment.
Estimated using the Kaplan-Meier method.
Estimated using the Kaplan-Meier method.
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The count and percentage of patients that reported a grade 3+ adverse event will be reported.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- trial label
- MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland 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
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0005
- source section id
- NCT04895735-om-0005
- source outcome index
- 5
- endpoint
- Frequency of MTAP Loss
- endpoint definition
- Assessed by immunohistochemistry. Will investigate correlation with enhanced response to pemetrexed. The associations of these markers with response will be done via Chi-square or Fisher's exact tests by cohort for categorical biomarkers and done via 2-sample t-tests (or the Wilcoxon Rank-Sum test) by cohort for continuous biomarker data. Descriptive statistics and tables will be reported.
- time origin
- Up to 3 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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
- NCT04895735
- outcome key
- om-0000
- source section id
- NCT04895735-om-0000
- source outcome index
- 0
- endpoint
- Confirmed Response Rate
- endpoint definition
- Evaluated by Response Evaluation Criteria in Solid Tumors version 1.1.
- time origin
- 24 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible and 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-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0001
- source section id
- NCT04895735-om-0001
- source outcome index
- 1
- endpoint
- Clinical Benefit Rate (CBR)
- endpoint definition
- CBR will be defined as the rate of patients with stable disease, partial response or complete response as their best response during treatment.
- time origin
- 24 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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
- NCT04895735
- outcome key
- om-0002
- source section id
- NCT04895735-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Estimated using the Kaplan-Meier method.
- time origin
- 3 years
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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
- NCT04895735
- outcome key
- om-0003
- source section id
- NCT04895735-om-0003
- source outcome index
- 3
- endpoint
- Progression-free Survival
- endpoint definition
- Estimated using the Kaplan-Meier method.
- time origin
- 30 months
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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
- NCT04895735
- outcome key
- om-0004
- source section id
- NCT04895735-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Adverse Events
- endpoint definition
- The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The count and percentage of patients that reported a grade 3+ adverse event will be reported.
- time origin
- 27 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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
- NCT04895735
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort A (Adenoid Cystic Carcinoma)
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 3)
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort B (Non-adenoid Cystic Carcinoma)
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 24
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort A
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort A1
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Cohort B (Non-adenoid Cystic Carcinoma)
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 24
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Cohort A
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Cohort A1
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- outcome key
- om-0004
- arm key
- OG002
- arm label
- Cohort B (Non-adenoid Cystic Carcinoma)
- regimen
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- analyzed count
- 24
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04895735-om-0004#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- harm key
- EG000
- source section id
- NCT04895735-ae
- event group key
- EG000
- event group label
- Cohort A (Adenoid Cystic Carcinoma)
- serious affected
- 3
- serious at risk
- 11
- other affected
- 10
- other at risk
- 11
- frequency threshold
- 0
- collection period
- Patient mortality was followed for 3 years and adverse events were followed for 27 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- harm key
- EG001
- source section id
- NCT04895735-ae
- event group key
- EG001
- event group label
- Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment
- serious affected
- 4
- serious at risk
- 9
- other affected
- 9
- other at risk
- 9
- frequency threshold
- 0
- collection period
- Patient mortality was followed for 3 years and adverse events were followed for 27 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoid-cystic-carcinoma
- nct id
- NCT04895735
- harm key
- EG002
- source section id
- NCT04895735-ae
- event group key
- EG002
- event group label
- Cohort B (Non-adenoid Cystic Carcinoma)
- serious affected
- 8
- serious at risk
- 25
- other affected
- 24
- other at risk
- 25
- frequency threshold
- 0
- collection period
- Patient mortality was followed for 3 years and adverse events were followed for 27 months
- 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
- setting source links
Preserved source evidence · Not medical advice