TriangleNCT02567422 · STUDY IN CONTEXT
Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for 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
According to the Cancer Therapy Evaluation Program National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v. 5). The highest grade experienced by the participant will be reported.
Dose limiting toxicities are protocol-specific adverse events considered at least possibly related to the study intervention. Graded according to NCI CTCAE v5.
Defined as the highest doses of cisplatin and berzosertib safely combined with radiation.
The maximum concentration ratio between Day -7 collections to Day 2 collections. Collection time points are baseline, 30 and 55 minutes after the start of M6620 infusion, 5, 15, 30 minutes, 1, 2, 4, 23 (Day 3), 48 (Day 4), and 72 hours (Day 5) after the end of M6620 infusion given on Day 2.
The maximum concentration of M6620 in the blood when aprepitant is also given.
Evaluated by Response Evaluation Criteria in Solid Tumors 1.1. Response is defined as complete response (disappearance of all target and non-target lesions) or partial response (at least a 30% decrease in the sum of diameters of target lesions from baseline).
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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- trial label
- Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for 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
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0000
- source section id
- NCT02567422-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants Experiencing Grade 3, 4, and 5 Adverse Events
- endpoint definition
- According to the Cancer Therapy Evaluation Program National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v. 5). The highest grade experienced by the participant will be reported.
- time origin
- Up to 6.5 years
- 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0001
- source section id
- NCT02567422-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants Experiencing a Dose Limiting Toxicities
- endpoint definition
- Dose limiting toxicities are protocol-specific adverse events considered at least possibly related to the study intervention. Graded according to NCI CTCAE v5.
- time origin
- Up to 3 weeks after completion of radiation therapy
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Dose limiting toxicities (DLTs) are only evaluated in participants during dose escalation (i.e. Dose Levels 1, 2, and 3). Participants not completing the treatment for reasons other than an adverse event (i.e. withdrawal or non-compliance with treatment) are excluded from the analysis. DLTs were not evaluated for participants enrolled in Dose Expansion.
- 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0002
- source section id
- NCT02567422-om-0002
- source outcome index
- 2
- endpoint
- Establish the Recommended Phase 2 Dose (RP2D)
- endpoint definition
- Defined as the highest doses of cisplatin and berzosertib safely combined with radiation.
- time origin
- Up to 7 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0003
- source section id
- NCT02567422-om-0003
- source outcome index
- 3
- endpoint
- Pharmacokinetic Characteristics of Berzosertib
- endpoint definition
- The maximum concentration ratio between Day -7 collections to Day 2 collections. Collection time points are baseline, 30 and 55 minutes after the start of M6620 infusion, 5, 15, 30 minutes, 1, 2, 4, 23 (Day 3), 48 (Day 4), and 72 hours (Day 5) after the end of M6620 infusion given on Day 2.
- time origin
- Up to Day 5
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Based on samples collected. PK was only collected in the dose escalation phase. PK was not collected for participants in the dose expansion arm.
- 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0004
- source section id
- NCT02567422-om-0004
- source outcome index
- 4
- endpoint
- Potential Drug-drug Interaction
- endpoint definition
- The maximum concentration of M6620 in the blood when aprepitant is also given.
- time origin
- Up to Day 5
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Based on samples collected. PK was only collected in the dose escalation phase. PK was not collected for participants in the dose expansion arm.
- 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0005
- source section id
- NCT02567422-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants Experiencing a Response
- endpoint definition
- Evaluated by Response Evaluation Criteria in Solid Tumors 1.1. Response is defined as complete response (disappearance of all target and non-target lesions) or partial response (at least a 30% decrease in the sum of diameters of target lesions from baseline).
- time origin
- Up to 6.5 years
- 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dose Level 2
- regimen
- Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Dose Level 3
- regimen
- Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Dose Level 3 Expansion
- regimen
- Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose Level 2
- regimen
- Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Dose Level 3
- regimen
- Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dose Escalation
- regimen
- Patients received different doses of M6620 (VX-970, berzosertib) by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dose Level 2
- regimen
- Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Dose Level 3
- regimen
- Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02567422-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- harm key
- EG000
- source section id
- NCT02567422-ae
- event group key
- EG000
- event group label
- Dose Level 1
- serious affected
- 5
- serious at risk
- 11
- other affected
- 11
- other at risk
- 11
- frequency threshold
- 5
- collection period
- Up to 6.5 years
- 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- harm key
- EG001
- source section id
- NCT02567422-ae
- event group key
- EG001
- event group label
- Dose Level 2
- serious affected
- 4
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Up to 6.5 years
- 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- harm key
- EG002
- source section id
- NCT02567422-ae
- event group key
- EG002
- event group label
- Dose Level 3
- serious affected
- 7
- serious at risk
- 11
- other affected
- 11
- other at risk
- 11
- frequency threshold
- 5
- collection period
- Up to 6.5 years
- 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-cancer-of-unknown-primary-cup
- nct id
- NCT02567422
- harm key
- EG003
- source section id
- NCT02567422-ae
- event group key
- EG003
- event group label
- Dose Level 3 Expansion
- serious affected
- 5
- serious at risk
- 15
- other affected
- 15
- other at risk
- 15
- frequency threshold
- 5
- collection period
- Up to 6.5 years
- 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