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NCT02500797 · CITED IN SOURCE DOCUMENTS

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-10-17

This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Who Achieved a Confirmed Response

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outcome · POSTED

Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution

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outcome · POSTED

Duration of Response

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outcome · POSTED

6-Month Clinical Benefit Rate [Initial Cohort]

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outcome · POSTED

6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts Only]

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outcome · POSTED

6-Month Clinical Benefit Rate [Expansion GIST Cohort Only]

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · NOT POSTED

PD-L1 Expression Assessed Using Immunohistochemistry (IHC)

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outcome · NOT POSTED

Change in Selected Biomarkers Measured in Serial Peripheral Blood

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outcome · NOT POSTED

Selected Biomarkers Measured in Tumor Tissue

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outcome · NOT POSTED

Confirmed Response in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression

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outcome · NOT POSTED

Duration of Response in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression

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outcome · NOT POSTED

PFS in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression

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outcome · NOT POSTED

OS in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * PRE-REGISTRATION ELIGIBILITY CRITERIA: * Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H\&E) and 20 unstained sarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility * REGISTRATION ELIGIBILITY CRITERIA: * Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review * Patients must have histologically confirmed liposarcoma (LPS) (only dedifferentiated and pleomorphic; well differentiated not eligible), undifferentiated pleomorphic sarcoma (UPS)/malignant fibrous histiocytoma (MFH), or gastrointestinal stromal tumor (GIST) * Measurable disease * Locally advanced/unresectable or metastatic disease * \>= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy * No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) * No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =\< 28 days before study registration; no treatment with nitrosourea or mitomycin =\< 42 days before study registration; for GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment * Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, version 4.0, grade 1 or less * No history of the following: * Active known or suspected autoimmune disease * Patients with human immunodeficiency virus (HIV) are eligible if the lymphocytes \> 350 cluster of differentiation (CD)4+ cells and no detectable viral load * Symptomatic, untreated, or uncontrolled brain metastases present * Active autoimmune colitis * Autoimmune panhypopituitarism * Autoimmune adrenal insufficiency * Known active hepatitis B or C * Hepatitis B can be defined as: * Hepatitis B surface antigen (HBsAg) \> 6 months * Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B * Persistent or intermittent elevation in alanine aminotransferase (ALT)/alanine aminotransferase (AST) levels * Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation * Hepatitis C can be defined as: * Hepatitis C antibody (Ab) positive * Presence of hepatitis C virus (HCV) ribonucleic acid (RNA) * Known active pulmonary disease with hypoxia defined as: * Oxygen saturation \< 85% on room air or * Oxygen saturation \< 88% despite supplemental oxygen * No systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration * Not pregnant and not nursing because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects; therefore for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \> 45 mL/min using the lean body mass formula only (Modified Cockcroft and Gault; Shargel and Yu 1985) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =\< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =\< 3 x ULN is permitted * AST/ALT =\< 3 x upper limit of normal (ULN) * Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH if free T4 is normal and patient is clinically euthyroid, patient is eligible * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Measurable disease * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Locally advanced/unresectable or metastatic disease * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patient MUST have had progressive disease (radiographic or clinical) while on arm 1 single agent nivolumab while registered to A091401 * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients removed from any immunotherapy for reasons other than progressive disease, including arm 1 single agent nivolumab of A091401, are NOT eligible for re-registration * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients must have completed a minimum of 10 weeks of single agent nivolumab on arm 1 of A091401 to be eligible for re-registration * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients must have completed study drug on arm 1 of A091401 (i.e., last dose of nivolumab) =\< 12 months of re-registration to crossover dual agent therapy * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): No treatment with immunotherapy =\< 21 days before re-registration; no treatment with biologic therapy, chemotherapy, investigational agent for malignancy, or radiation =\< 28 days before re-registration; no treatment with nitrosourea or mitomycin =\< 42 days before re-registration * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients should have resolution of any toxic effects of prior therapy (except fatigue and alopecia) to NCI CTCAE, version 4.0, grade 1 or less, including immune toxicity * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): No systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of re-registration * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Not pregnant and not nursing because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to re-registration is required * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): ECOG performance status 0 or 1 * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): ANC \>= 1,500/mm\^3 * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Platelet count \>= 100,000/mm\^3 * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Creatinine =\< 1.5 ULN OR calc. creatinine clearance \> 45 mL/min (using lean body mass formula only \[Modified Cockcroft and Gault; Shargel and Yu 1985\]) * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Total bilirubin =\< 1.5 x ULN in absence of Gilbert disease (total bilirubin =\< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =\< 3 x ULN is permitted * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): AST/ALT =\< 3 x ULN * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): TSH WNL; supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to Arm II.
    intervention Names
    1. Other: Laboratory Biomarker Analysis
    2. Biological: Nivolumab
    3. Other: Quality-of-Life Assessment
    label
    Arm I (nivolumab)
    type
    EXPERIMENTAL
  2. description
    Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    intervention Names
    1. Biological: Ipilimumab
    2. Other: Laboratory Biomarker Analysis
    3. Biological: Nivolumab
    4. Other: Quality-of-Life Assessment
    label
    Arm II (nivolumab, ipilimumab)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (nivolumab, ipilimumab)
    description
    Given IV
    name
    Ipilimumab
    other Names
    1. Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
    2. BMS-734016
    3. Ipilimumab Biosimilar CS1002
    4. MDX-010
    5. MDX-CTLA4
    6. Yervoy
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm I (nivolumab)
    2. Arm II (nivolumab, ipilimumab)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  3. arm Group Labels
    1. Arm I (nivolumab)
    2. Arm II (nivolumab, ipilimumab)
    description
    Given IV
    name
    Nivolumab
    other Names
    1. BMS-936558
    2. CMAB819
    3. MDX-1106
    4. NIVO
    5. Nivolumab Biosimilar CMAB819
    6. ONO-4538
    7. Opdivo
    type
    BIOLOGICAL
  4. arm Group Labels
    1. Arm I (nivolumab)
    2. Arm II (nivolumab, ipilimumab)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
CROSSOVER
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
164
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Categorical data analysis and logistic regression will be used to evaluate the associations between PD-L1 expression (by IHC) and clinical outcome (e.g., response, clinical benefit, progression-free survival, and survival). Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
    measure
    PD-L1 Expression Assessed Using Immunohistochemistry (IHC)
    time Frame
    Up to 3 years
  2. description
    Summary statistics will be used to for describing changes across time. The time course of biomarker outcomes will be investigated graphically, by summary plots or individual patient plots. If there is suggestion of meaningful trend, methods such as linear mixed models may be used to characterize the pattern of change over time. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
    measure
    Change in Selected Biomarkers Measured in Serial Peripheral Blood
    time Frame
    Baseline to up to 3 years
  3. description
    Categorical data analysis and logistic regression will be used to correlated biomarkers with and clinical outcome (e.g., response, clinical benefit, time to progression, progression free survival, and survival) within each study component. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
    measure
    Selected Biomarkers Measured in Tumor Tissue
    time Frame
    Up to week 6
  4. description
    Confirmed response will be evaluated in patients who crossover from single agent nivolumab to dual agent treatment following progression.
    measure
    Confirmed Response in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression
    time Frame
    Up to 3 years
  5. description
    Evaluated using Kaplan-Meier methodology.
    measure
    Duration of Response in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression
    time Frame
    Time from first response to progression, assessed up to 3 years
  6. description
    Evaluated using Kaplan-Meier methodology.
    measure
    PFS in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression
    time Frame
    Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years
  7. description
    Evaluated using Kaplan-Meier methodology.
    measure
    OS in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression
    time Frame
    Time from randomization to death from any cause, assessed up to 3 years
primary Outcomes
  1. description
    The number of participants who achieved a confirmed response is defined as the number of patients having a best objective tumor status of complete response (CR) or partial response (PR) lasting at least 4 weeks as determined using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites).
    measure
    Number of Participants Who Achieved a Confirmed Response
    time Frame
    Up to 44 months
secondary Outcomes
  1. description
    The number of participants who experienced at least one grade 3 or higher adverse event (AE) regardless of attribution. AEs are graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018).
    measure
    Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution
    time Frame
    Up to 4 weeks after completion of study treatment
  2. description
    Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).
    measure
    Duration of Response
    time Frame
    Time from first response to progression, assessed up to 3 years
  3. description
    The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
    measure
    6-Month Clinical Benefit Rate [Initial Cohort]
    time Frame
    At 6 months
  4. description
    The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
    measure
    6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts Only]
    time Frame
    At 6 months
  5. description
    The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
    measure
    6-Month Clinical Benefit Rate [Expansion GIST Cohort Only]
    time Frame
    At 6 months
  6. description
    Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).
    measure
    Progression-free Survival (PFS)
    time Frame
    Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years
  7. description
    Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
    measure
    Overall Survival (OS)
    time Frame
    Time from randomization to death from any cause, assessed up to 3 years
Full study description
brief Summary
This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.
detailed Description
PRIMARY OBJECTIVE: I. To evaluate the confirmed response rate of single agent nivolumab and dual agent nivolumab plus ipilimumab in patients with locally advanced/unresectable or metastatic soft tissue sarcoma. SECONDARY OBJECTIVES: I. To evaluate adverse event rates (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]4.0) within each treatment arm. II. To evaluate duration of response, clinical benefit rate, time to progression, progression-free survival, and overall survival within each treatment arm. CORRELATIVE SCIENCE OBJECTIVES: I. To potentially detect an early signal of confirmed response rate within a histologically defined patient cohort. II. To assess the potential association between programmed cell death 1 ligand 1 (PD-L1) expression (by immunohistochemistry \[IHC\]) and clinical outcome, within each treatment. III. To evaluate associations between selected biomarker measured in serial peripheral blood and with clinical efficacy, within each treatment. IV. To evaluate the association between selected biomarker measured in tumor tissue with clinical efficacy, within each treatment. V. To evaluate the association between baseline tumor mutational burden and neoantigen production with clinical efficacy within each treatment. EXPLORATORY PHASE II OBJECTIVES (CROSSOVER TREATMENT): I. To evaluate secondary endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab. II. To evaluate correlative science objectives endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to Arm II. ARM II: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator. After completion of study treatment, patients are followed up at 4 weeks and then every 6 months 3 years.
Source references
references
  1. citation
    Seligson ND, Chen JL, Goodrich AC, Van Tine BA, Campbell JD, Richards AL, Antonescu CR, Liebner DA, Milhem MM, Streicher H, Tap WD, Schwartz GK, George S, D'Angelo SP. A multicenter, randomized, non-comparative, phase II study of nivolumab +/- ipilimumab for patients with metastatic sarcoma (Alliance A091401): expansion cohorts and correlative analyses. J Immunother Cancer. 2024 Sep 28;12(9):e009472. doi: 10.1136/jitc-2024-009472.
    pmid
    39343511
    type
    DERIVED
  2. citation
    D'Angelo SP, Mahoney MR, Van Tine BA, Atkins J, Milhem MM, Jahagirdar BN, Antonescu CR, Horvath E, Tap WD, Schwartz GK, Streicher H. Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials. Lancet Oncol. 2018 Mar;19(3):416-426. doi: 10.1016/S1470-2045(18)30006-8. Epub 2018 Jan 19.
    pmid
    29370992
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        coma.</li><li>Zero of 10 patients with leiomyosarcoma.</li><li>The overall response rate was 18%.</li></ul></div></li><li>The phase II <a href="/clinicaltrials/NCT02500797">Alliance A091401</a> study (NCT02500797) randomly assigned patients to receive nivolumab (n = 43) versus nivolumab and ipilimumab (n = 42) for the treatment
        end
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      2. context exact
        iomyosarcoma.</li><li>The overall response rate was 18%.</li></ul></div></li><li>The phase II <a href="/clinicaltrials/NCT02500797">Alliance A091401</a> study (NCT02500797) randomly assigned patients to receive nivolumab (n = 43) versus nivolumab and ipilimumab (n = 42) for the treatment of different soft tissue sarcomas.[<a hre
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      source title
      Soft Tissue Sarcoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 21, 2025
        datetime
        2025-02-21T12:00:00Z
        display
        February 21, 2025

    Preserved source evidence · Not medical advice