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NCT03108131 · STUDY IN CONTEXT

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

To evaluate the efficacy of cobimetinib plus atezolizumab (COTEZO) in cohorts of advanced rare tumors using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Efficacy as determined by complete response and partial response.

Source null

→

secondary · POSTED

Disease Control Rate (DCR) includes patients with tumor maintained at Stable Disease (SD), Partial Response (PR) and Complete Response (CR).

Source null

→

secondary · POSTED

Progression free survival (PFS) is defined as the time from randomization until first evidence of disease progression or death

Source null

→

secondary · POSTED

Overall survival (OS) is defined as the time from randomization to death

2 of the patients was not included in the analysis of PFS because their surgical cancellations were unrelated to progressive disease.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-skin-cancer
nct id
NCT03108131
trial label
Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors
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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    outcome key
    om-0000
    source section id
    NCT03108131-om-0000
    source outcome index
    0
    endpoint
    Overall Response Rate (ORR)
    endpoint definition
    To evaluate the efficacy of cobimetinib plus atezolizumab (COTEZO) in cohorts of advanced rare tumors using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Efficacy as determined by complete response and partial response.
    time origin
    Patient will be on study up to 3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    outcome key
    om-0001
    source section id
    NCT03108131-om-0001
    source outcome index
    1
    endpoint
    Disease Control Rate (DCR)
    endpoint definition
    Disease Control Rate (DCR) includes patients with tumor maintained at Stable Disease (SD), Partial Response (PR) and Complete Response (CR).
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    outcome key
    om-0002
    source section id
    NCT03108131-om-0002
    source outcome index
    2
    endpoint
    Progression-Free Survival (PFS)
    endpoint definition
    Progression free survival (PFS) is defined as the time from randomization until first evidence of disease progression or death
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    outcome key
    om-0003
    source section id
    NCT03108131-om-0003
    source outcome index
    3
    endpoint
    Overall Survival
    endpoint definition
    Overall survival (OS) is defined as the time from randomization to death
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    2 of the patients was not included in the analysis of PFS because their surgical cancellations were unrelated to progressive disease.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Small Bowel Adenocarcinoma
    regimen
    Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03108131-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Small Bowel Adenocarcinoma
    regimen
    Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03108131-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Small Bowel Adenocarcinoma
    regimen
    Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03108131-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Small Bowel Adenocarcinoma
    regimen
    Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03108131-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03108131
    harm key
    EG000
    source section id
    NCT03108131-ae
    event group key
    EG000
    event group label
    Small Bowel Adenocarcinoma
    serious affected
    0
    serious at risk
    20
    other affected
    9
    other at risk
    20
    frequency threshold
    0
    collection period
    3 years
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice