TriangleNCT01769222 · STUDY IN CONTEXT
Ipilimumab and Local Radiation for Selected Solid Tumors
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Data will be summarized using Kaplan-Meier estimates for time to event data.
Data will be summarized using Kaplan-Meier estimates for time to event data.
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-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- trial label
- Ipilimumab and Local Radiation for Selected Solid Tumors
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0000
- source section id
- NCT01769222-om-0000
- source outcome index
- 0
- endpoint
- Dose-limiting Toxicity
- endpoint definition
- Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- time origin
- 4 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This study did not proceed to Phase 2 (ipilimumab plus radiation combination therapy).
- 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-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0001
- source section id
- NCT01769222-om-0001
- source outcome index
- 1
- endpoint
- Immune Response (Phase 2 Only)
- endpoint definition
- Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
- time origin
- 4 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This was a study phase 2 outcome, and no participants were enrolled in study phase 2.
- 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-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0002
- source section id
- NCT01769222-om-0002
- source outcome index
- 2
- endpoint
- Immune Response (Phase 2 Only)
- endpoint definition
- Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
- time origin
- 8 weeks
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0003
- source section id
- NCT01769222-om-0003
- source outcome index
- 3
- endpoint
- Response Rate (Phase 2 Only)
- endpoint definition
- Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
- time origin
- 8 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This was a study phase 2 outcome, and no participants were enrolled in study phase 2.
- 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-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0004
- source section id
- NCT01769222-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival (Phase 2 Only)
- endpoint definition
- Data will be summarized using Kaplan-Meier estimates for time to event data.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This was a study phase 2 outcome, and no participants were enrolled in study phase 2.
- 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-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0005
- source section id
- NCT01769222-om-0005
- source outcome index
- 5
- endpoint
- Duration of Response (Phase 2 Only)
- endpoint definition
- Data will be summarized using Kaplan-Meier estimates for time to event data.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This was a study phase 2 outcome, and no participants were enrolled in study phase 2.
- 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-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Ipilimumab 25 mg
- regimen
- Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Ipilimumab 25 mg and Radiation Therapy
- regimen
- Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Ipilimumab 25 mg
- regimen
- Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Ipilimumab 25 mg and Radiation Therapy
- regimen
- Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Ipilimumab 25 mg
- regimen
- Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Ipilimumab 25 mg and Radiation Therapy
- regimen
- Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Ipilimumab 25 mg
- regimen
- Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Ipilimumab 25 mg and Radiation Therapy
- regimen
- Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Ipilimumab 25 mg
- regimen
- Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Ipilimumab 25 mg and Radiation Therapy
- regimen
- Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Ipilimumab 25 mg
- regimen
- Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Ipilimumab 25 mg and Radiation Therapy
- regimen
- Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01769222-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- harm key
- EG000
- source section id
- NCT01769222-ae
- event group key
- EG000
- event group label
- Ipilimumab 25 mg
- serious affected
- 0
- serious at risk
- 3
- other affected
- 1
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Source null
- 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-rectal-cancer-stage-iv-recurrent-dbf7a1d5
- nct id
- NCT01769222
- harm key
- EG001
- source section id
- NCT01769222-ae
- event group key
- EG001
- event group label
- Ipilimumab 25 mg and Radiation Therapy
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Source null
- 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