TriangleNCT05041062 · STUDY IN CONTEXT
A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma
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
The response of participant's tumor to treatment with nivolumab and ipilimumab before surgery by analyzing tissue samples collected from participant during surgery for the presence of cancerous tumour cells. Major pathologic response will be defined as tissue samples containing less than or equal to 10% of residual (leftover) tumor/cancer in the tissue after surgery.
The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab before surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0 for up to 30 days after surgery.
Number of participants who complete treatment with nivolumab and ipilimumab before surgery and proceed to surgery without extended treatment-related delays or progression precluding surgery as assessed by clinical /study records.
Overall survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.
Progression-free survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.
The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab after surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0.
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-peritoneal-neoplasm
- nct id
- NCT05041062
- trial label
- A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma
- 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0000
- source section id
- NCT05041062-om-0000
- source outcome index
- 0
- endpoint
- Major Pathologic (Disease) Response of Tumor to Nivolumab Combined With Ipilimumab Before Surgery
- endpoint definition
- The response of participant's tumor to treatment with nivolumab and ipilimumab before surgery by analyzing tissue samples collected from participant during surgery for the presence of cancerous tumour cells. Major pathologic response will be defined as tissue samples containing less than or equal to 10% of residual (leftover) tumor/cancer in the tissue after surgery.
- time origin
- 24 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data not collected.
- 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-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0001
- source section id
- NCT05041062-om-0001
- source outcome index
- 1
- endpoint
- Rate of Participants Who Report Serious Side Effects to Nivolumab Combined With Ipilimumab Before Surgery (Neoadjuvant Treatment)
- endpoint definition
- The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab before surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0 for up to 30 days after surgery.
- time origin
- 3 weeks (timeframe for surgery ) + 30 days (timeframe for assessing side effects after surgery)
- 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-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0002
- source section id
- NCT05041062-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants Who Proceed to Surgery Without Delays After Receiving Nivolumab Combined With Ipilimumab
- endpoint definition
- Number of participants who complete treatment with nivolumab and ipilimumab before surgery and proceed to surgery without extended treatment-related delays or progression precluding surgery as assessed by clinical /study records.
- time origin
- 19 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-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0003
- source section id
- NCT05041062-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery
- endpoint definition
- Overall survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.
- time origin
- 42 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data not collected.
- 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-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0004
- source section id
- NCT05041062-om-0004
- source outcome index
- 4
- endpoint
- Progression-Free Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery
- endpoint definition
- Progression-free survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.
- time origin
- 42 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data not collected.
- 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-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0005
- source section id
- NCT05041062-om-0005
- source outcome index
- 5
- endpoint
- Rate of Participants Who Report Serious Side Effects to Taking Nivolumab Combined With Ipilimumab After Surgery (Adjuvant Treatment)
- endpoint definition
- The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab after surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0.
- time origin
- 12 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Neither of the two enrolled patients received study drug (nivolumab/ipilimumab) after surgery.
- 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-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Participants in Study Who Have Mesothelioma
- regimen
- Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05041062-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0001
- arm key
- OG000
- arm label
- All Participants in Study Who Have Mesothelioma
- regimen
- Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05041062-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0002
- arm key
- OG000
- arm label
- All Participants in Study Who Have Mesothelioma
- regimen
- Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05041062-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0003
- arm key
- OG000
- arm label
- All Participants in Study Who Have Mesothelioma
- regimen
- Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05041062-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0004
- arm key
- OG000
- arm label
- All Participants in Study Who Have Mesothelioma
- regimen
- Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05041062-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT05041062
- outcome key
- om-0005
- arm key
- OG000
- arm label
- All Participants in Study Who Have Mesothelioma
- regimen
- Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05041062-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-peritoneal-neoplasm
- nct id
- NCT05041062
- harm key
- EG000
- source section id
- NCT05041062-ae
- event group key
- EG000
- event group label
- All Participants in Study Who Have Mesothelioma
- serious affected
- 2
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 5
- collection period
- 12 weeks
- 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