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Active, not recruitingNCT04458922Updated Jul 31, 2026Results posted

Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma

A Phase 2 interventional study of Atezolizumab and Biopsy Procedure in Central Chondrosarcoma, Grade 2, Central Chondrosarcoma, Grade 3 and Dedifferentiated Chondrosarcoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 15 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
2 Years and older
Sex
All
01

Study summary

This phase II trial studies how well atezolizumab works in treating patients with chondrosarcoma or clear cell sarcoma that is newly diagnosed, cannot be removed by surgery (unresectable), or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVE:

I. Determine the objective response rates (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 of atezolizumab in adult (>= 18 years) patients with clear cell sarcoma (CCS) and chondrosarcoma (CS).

SECONDARY OBJECTIVES:

I. Determine duration of response (DOR) using RECIST v 1.1 and/or change in clinical symptoms (time frame: baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination).

II. Measure progression-free survival (PFS) time (time frame: baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination).

III. Assess the number of activated CD8+ T cells infiltrating the tumor before and after atezolizumab treatment, and correlate treatment-induced changes with clinical response.

EXPLORATORY OBJECTIVES:

I. Compare RECIST v 1.1 versus (vs) immune RECIST (iRECIST) in patients with CCS and CS on atezolizumab.

II. Examine changes in PD-1/PD-L1 expression in the tumor microenvironment before and after atezolizumab treatment, and correlate treatment-induced changes with clinical response.

III. Evaluate potential associations between atezolizumab activity and tumor genomic alterations.

OUTLINE:

Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.

After completion of study treatment, patients are followed up to 90 days.

02

Conditions studied

  • Central Chondrosarcoma, Grade 2
  • Central Chondrosarcoma, Grade 3
  • Dedifferentiated Chondrosarcoma
  • Metastatic Clear Cell Sarcoma of Soft Tissue
  • Metastatic Primary Central Chondrosarcoma
  • Unresectable Primary Central Chondrosarcoma
03

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have documented EWSR1/ATF1 or EWSR1/CREB1 translocation or histologically confirmed clear cell sarcoma, documented grade 2 or 3 conventional chondrosarcoma, or documented dedifferentiated chondrosarcoma. The disease must not be curable by surgery
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
  • Patients with newly diagnosed, unresectable, metastatic and measurable clear cell sarcoma, EWSR1/ATF1 or EWSR1/CREB1 translocation, grade 2 or 3 conventional chondrosarcoma, or dedifferentiated chondrosarcoma will also be eligible if they show clinical evidence of disease progression (including history and increasing physical symptoms). On-study documentation will include a physician's rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain)
  • Age >= 2 years at the National Cancer Institute (NCI) Clinical Center (>= 12 years at other participating sites)
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky or Lansky >= 70%)
  • Life expectancy of greater than 3 months
  • Absolute neutrophil count >= 1,000/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 8 g/dL
  • Total bilirubin =\< institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x institutional ULN (AST and/or ALT =\< 5 x ULN for patients with liver involvement)
  • Alkaline phosphatase =\< 2.5 x ULN (=\< 5 x ULN for patients with documented liver involvement or bone metastases)
  • Creatinine:

    • For adult patients (>= 18 years of age): >= 30 mL/min/1.73 m\^2 by Cockcroft-Gault
    • For pediatric patients (\< 18 years of age), a serum creatinine based on age and gender as follows:

      • Age: 2 to \< 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) 0.8 (female)
      • Age: 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male) 1 (female)
      • Age: 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) 1.2 (female)
      • Age: 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) 1.4 (female)
      • Age: 16 to \< 18 years; Maximum serum creatinine (mg/dL): 1.7 (male) 1.4 (female)
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for >= 1 month after treatment of the brain metastases
  • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first 2 cycles of therapy
  • Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Willingness to provide biopsy samples for research purposes (patients >= 18 years of age only)
  • Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document or a parent/guardian able to do the same

Exclusion criteria

Exclusion Criteria:

  • Any prior therapy must have been completed >= 4 weeks or, if known, >= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity. Patients should be at least 6 weeks out from nitrosoureas and mitomycin C. Prior definitive radiation should have been completed >= 4 weeks or palliative radiation should have been completed >= 2 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the principal investigator [PI's] discretion). Patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment). A patient who has received a cumulative dose of > 350 mg/m\^2 of anthracycline (regardless of cardioprotectant) may only be enrolled if their ejection fraction measured by an echocardiogram is within normal institutional limits
  • Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

    • Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met:

      • Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose
      • No history of severe immune-related adverse effects from anti-CTLA-4 (NCI Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)
  • Treatment with any other investigational agent within 4 weeks (or within five half lives of the investigational product, whichever is shorter) prior to cycle 1, day 1 (minimum of 1 week between prior therapy and study enrollment). Patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an "early phase I study" or "pre-phase I study" where a sub-therapeutic dose of drug is administered) at the coordinating center PI's discretion, and should have recovered to eligibility levels from any toxicities
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon-alpha or interleukin-2 [aldesleukin]) within 6 weeks prior to cycle 1, day 1
  • Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone [ > 10 mg/day], cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1.

    • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
    • The use of inhaled corticosteroids and systemic mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
  • Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies (i.e., antibodies with generic names ending in "ximab" or "zumab", respectively) or fusion proteins
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because atezolizumab is an investigational agent with the unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding should be discontinued if the mother is treated with atezolizumab
  • Patients with a history of human immunodeficiency virus (HIV)-positive on antiretroviral therapy are eligible with an undetectable viral load. For those patients, an HIV viral load test must be completed within 28 days prior to enrollment
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease.

    • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
  • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis.

    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
    • Patients with autoimmune hyperthyroid disease not requiring immunosuppressive treatment may be eligible
    • Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:

      • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
      • Rash must cover less than 10% of body surface area (BSA)
      • Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
      • No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Patients with active tuberculosis (TB) are excluded
  • Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
  • Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
  • Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
  • Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab

    • Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Treatment (atezolizumab)

    Patients receive atezolizumab IV over 30-60 minutes on ay 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and undergo biopsy and collection of blood samples on study.

    Drug: Atezolizumab · Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography

Interventions

  • DrugAtezolizumab

    Given IV

    Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq

  • ProcedureBiopsy Procedure

    Correlative studies

    Also known as: Biopsy, BIOPSY_TYPE, Bx

  • ProcedureBiospecimen Collection

    Correlative studies

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureComputed Tomography

    Undergo CT scan

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

05

What researchers measure

Primary outcomes

  1. Objective Response Rates (ORR)

    ORR was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, which involves the following response definitions. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

    Time frame: Baseline until confirmation of progressive disease or response (complete or partial) as defined by RECIST v1.1, an average of 4 months.

Secondary outcomes

  1. Duration of Response (DOR) or Change in Clinical Symptoms

    Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and/or change in clinical symptoms. Progressive Disease (PD): is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

    Time frame: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years

  2. Progression-free Survival (PFS) Time

    PFS is the time interval from start of treatment to documented evidence of disease progression, measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, or death from any cause, whichever comes first. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

    Time frame: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years

  3. Number of Activated Cluster of Differentiation 8 (CD8+) T Cells Infiltrating the Tumor

    Activated CD8+ T cells will be detected by multiplex immunofluorescence assays and will be defined by the expression of T cell receptor (TCR) activation (Zeta chain phosphorylation) or phosphorylated Zap70 (pY493); CD8+ cells present within the tumor section that are positive for these markers will be quantified.

    Time frame: Up to 3 years on Cycle 1 Day 1 and Cycle 3 Day 1

Other outcomes

  1. Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

    Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

    Time frame: Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively.

06

Results

Posted Oct 23, 2023

Participant flow

Participant flow — Overall Study
MilestoneArm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)
Started999
Completed001
Not completed998
Withdrew: Withdrawal by subject102
Withdrew: Protocol -specified withdrawal criterion met001
Withdrew: Adverse event100
Withdrew: Started new study001
Withdrew: Progressive disease682
Withdrew: Death102
Withdrew: Participant started chemotherapy010

Outcome measures

PrimaryObjective Response Rates (ORR)

ORR was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, which involves the following response definitions. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Time frame:
Baseline until confirmation of progressive disease or response (complete or partial) as defined by RECIST v1.1, an average of 4 months.
Reported as:
Number · percentage of participants
Objective Response Rates (ORR)
percentage of participantsArm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)
Complete Response000
Partial Response000
Stable Disease33.3333.3333.33
Progressive Disease55.5666.6744.44
Unknown (not assessed)11.11022.22
SecondaryDuration of Response (DOR) or Change in Clinical Symptoms

Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and/or change in clinical symptoms. Progressive Disease (PD): is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Time frame:
Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years

No measurements were reported for this outcome.

SecondaryProgression-free Survival (PFS) Time

PFS is the time interval from start of treatment to documented evidence of disease progression, measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, or death from any cause, whichever comes first. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Time frame:
Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years
Reported as:
Median · Months
Progression-free Survival (PFS) Time
MonthsArm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)
Progression-free Survival (PFS) Time2.66 (2.04 to NA)3.22 (2.07 to NA)2.04 (1.22 to NA)
SecondaryNumber of Activated Cluster of Differentiation 8 (CD8+) T Cells Infiltrating the Tumor

Activated CD8+ T cells will be detected by multiplex immunofluorescence assays and will be defined by the expression of T cell receptor (TCR) activation (Zeta chain phosphorylation) or phosphorylated Zap70 (pY493); CD8+ cells present within the tumor section that are positive for these markers will be quantified.

Time frame:
Up to 3 years on Cycle 1 Day 1 and Cycle 3 Day 1
Reported as:
Median · Biomarker-positive cell/mm^2
Number of Activated Cluster of Differentiation 8 (CD8+) T Cells Infiltrating the Tumor
Biomarker-positive cell/mm^2Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)
Activated T Cells (CD8+ CD3ζ pY142+) in Tumor Biopsy Specimen Collected on Cycle 1 Day 10 (NA to 15)NA (NA to NA)0 (NA to 54)
Activated T Cells (CD8+ CD3ζ pY142+) in Tumor Biopsy Specimen Collected on Cycle 3 Day 14 (NA to 27)NA (NA to NA)1 (NA to 44)
Other pre-specifiedNumber of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Time frame:
Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively.
Reported as:
Count of participants · Participants
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
ParticipantsArm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)989

Adverse events

Collected over Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)1/9 (11.1%)5/9 (55.6%)9/9 (100%)
Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)0/9 (0%)1/9 (11.1%)8/9 (88.9%)
Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)2/9 (22.2%)6/9 (66.7%)9/9 (100%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventArm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)
AnemiaBlood and lymphatic system disorders2/90/91/9
Abdominal painGastrointestinal disorders0/90/91/9
Allergic reactionImmune system disorders0/90/91/9
Back painMusculoskeletal and connective tissue disorders0/90/91/9
ChillsGeneral disorders0/90/91/9
ConfusionPsychiatric disorders0/90/91/9
Death NOSGeneral disorders0/90/91/9
DyspneaRespiratory, thoracic and mediastinal disorders0/90/91/9
HyperglycemiaMetabolism and nutrition disorders0/90/91/9
Musculoskeletal and connective tissue disorder - Other, Gluteal muscle myonecrosisMusculoskeletal and connective tissue disorders0/90/91/9
Most frequent other events
Showing 10 of 126
Most frequent other events
EventArm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)
AnemiaBlood and lymphatic system disorders7/91/94/9
AnorexiaMetabolism and nutrition disorders7/90/92/9
FatigueGeneral disorders7/96/91/9
DyspneaRespiratory, thoracic and mediastinal disorders2/91/95/9
FeverGeneral disorders5/91/92/9
HyperglycemiaMetabolism and nutrition disorders5/91/94/9
Aspartate aminotransferase increasedInvestigations4/90/90/9
ConstipationGastrointestinal disorders2/91/94/9
HypoalbuminemiaMetabolism and nutrition disorders4/90/94/9
NauseaGastrointestinal disorders4/91/93/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)Total
<=18 years0000
Between 18 and 65 years97521
>=65 years0246
Age, Continuous
Age, Continuous(years)Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)Total
Mean37.11 ± 7.952.89 ± 11.464.89 ± 9.5751.63 ± 14.89
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)Total
Female52310
Male47617
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)Total
Hispanic or Latino3104
Not Hispanic or Latino57921
Unknown or Not Reported1102
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)Total
American Indian or Alaska Native0000
Asian1102
Native Hawaiian or Other Pacific Islander0000
Black or African American1001
White66820
More than one race0000
Unknown or Not Reported1214
Region of Enrollment
Region of Enrollment(participants)Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)Total
Canada0101
United States98926
07

Study locations

15 sites
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • UF Health Cancer Institute - Gainesville
    Gainesville, Florida 32610, United States
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • National Cancer Institute Developmental Therapeutics Clinic
    Bethesda, Maryland 20892, United States
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
  • NCI - Center for Cancer Research
    Bethesda, Maryland 20892, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Siteman Cancer Center-South County
    St Louis, Missouri 63129, United States
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • UT MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • University Health Network-Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 10, 2022
  • Informed consent form · Nov 10, 2022
  • Informed consent form · Nov 10, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

09

Registry details

Key details

Study ID
NCT04458922
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 7, 2020
Start date
Oct 5, 2020
Primary completion
Nov 28, 2022
Completion
Dec 17, 2026 (estimated)
Results posted
Oct 23, 2023
Last update
Jul 31, 2026

Study contacts

A P Chen
principal investigator · National Cancer Institute LAO

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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