Experimental combo for tough cancers shows early promise, but trial halted
NCT ID NCT02298153
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of two drugs—atezolizumab (an immunotherapy) and epacadostat (an oral drug that helps the immune system attack cancer)—in 29 patients with advanced lung or bladder cancer that had already been treated with chemotherapy. The main goal was to check safety and find the right dose. The trial was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atezolizumab (immunotherapy) and epacadostat (oral drug that boosts immune response)
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced lung and bladder cancers that have stopped responding to standard chemotherapy.
- What could go wrong
- This was a very early (Phase 1) safety study with only 29 participants, and it was terminated early, so we don't know if the combination works or is safe long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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29 people
The number who actually took part.
- Started
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Jan 2015
- Finished
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Nov 2017
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female subjects, age 18 years or older * Histologically or cytologically confirmed NSCLC * Stage IIIB or Stage IV NSCLC who are not candidates for multimodality treatment and have received at least 1 line of standard platinum-based therapy: * Prior systemic regimens must include at least 2 cycles of a platinum-based therapy and may include platinum therapy used as a radiosensitizer. Maintenance chemotherapy is allowed. * Tumors with driver mutations (epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive) should have had disease progression or been intolerant to the standard tyrosine-kinase inhibitor (TKI), and should include a second line TKI where such therapy is available and indicated. * Subjects initially treated with a platinum regimen for Stage IIIB disease who later develop metastatic disease and are re-treated with a platinum regimen are allowed. * Histologically or cytologically confirmed urothelial carcinoma. * Stage IV locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy or had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Presence of measurable disease per RECIST v1.1 * Availability of an adequate archival tumor specimen or willingness to undergo a pretreatment tumor biopsy. * Subjects enrolled in Expansion Cohort 3 must be willing to have 2 on-treatment tumor biopsies. * For males and females of child-bearing potential, willingness to use adequate birth control through 90 days after the last dose of epacadostat or atezolizumab. Exclusion Criteria: * Laboratory and medical history parameters not within protocol-defined range. * Current treatment with an investigational study drug or immunological-based agent for any reason, or receipt of anticancer medication within 21 days or 5 half-lives (whichever is longer) before first dose. * Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor. * Prior monoclonal antibody within 4 weeks before study Day 1, or has not recovered from adverse events due to agents administered more than 4 weeks earlier. * Has an active or inactive autoimmune process. * Has a history of pneumonitis or idiopathic pulmonary fibrosis, or evidence of interstitial lung disease. * Prior radiotherapy within 2 weeks of therapy; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. * Untreated central nervous system (CNS) metastases or CNS metastases that have progressed after completion of radiotherapy. * Use of systemic corticosteroids ≤ 2 weeks before Cycle 1 Day 1. * Currently pregnant or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Harvard-Mass General Hospital
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258, United States
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University of Washington
Seattle, Washington, 98109, United States
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Yale University
New Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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