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NCT03085914 · REGISTRY CONDITION SEARCH

A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2022-09-23

This was an open-label, nonrandomized, Phase 1/2 study designed to determine the safety, tolerability, and efficacy of epacadostat when given in combination with pembrolizumab and 7 different chemotherapy regimens described as Treatment Groups A through G below (see Study Drug and Background Therapies, Dose, and Mode of Administration). Phase 1 consisted of a 3 + 3 + 3 design intended to determine the MTD or PAD of epacadostat when given in combination with pembrolizumab and chemotherapy; efficacy was also explored. Phase 2 was designed to enroll efficacy expansion cohorts to further evaluate the safety, tolerability, and efficacy of epacadostat at the MTD or PAD (as selected in Phase 1) when given in combination with pembrolizumab and chemotherapy. Each efficacy expansion cohort was to enroll participants with 1 specific type of advanced or metastatic solid tumor. Additional cohorts (ie, the mandatory biopsy cohorts) were designed to evaluate changes in the tumor microenvironment in participants with any advanced or metastatic solid tumor who had progressed on previous therapy with a PD-1 or a PD-L1 inhibitor. No participants were enrolled in any Phase 2 efficacy expansion cohort, or in any Phase 2 mandatory biopsy cohort receiving Treatment A, B, F, or G. Phase 2 mandatory biopsy cohort participants received Treatments C, D, or E (ie, were included in Treatment Groups C, D, or E). Participants were assigned to a treatment group based on the chemotherapy regimen most appropriate for their tumor type.

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

Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

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outcome · POSTED

Phases 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Phases 1 and 2: Objective Response Rate (ORR)

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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: * Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors. * Presence of measurable disease per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Laboratory and medical history parameters not within the Protocol-defined range. * Receipt of anticancer medications or investigational drugs within the Protocol-defined intervals before the first administration of study drug. * Previous radiotherapy within 2 weeks of starting study therapy. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has not recovered to ≤ Grade 1 from toxic effects of previous therapy and/or complications from previous surgical intervention before starting study therapy. * Receipt of a live vaccine within 30 days of planned start of study therapy. * Active infection requiring systemic therapy. * Subjects who have any active or inactive autoimmune disease or syndrome. * Women who are pregnant or breastfeeding.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Epacadostat + pembrolizumab + mFOLFOX6 (oxaliplatin, leucovorin, 5-fluorouracil)
    intervention Names
    1. Drug: Epacadostat
    2. Drug: Pembrolizumab
    3. Drug: Oxaliplatin
    4. Drug: Leucovorin
    5. Drug: 5-Fluorouracil
    label
    Treatment Group A
    type
    EXPERIMENTAL
  2. description
    Epacadostat + pembrolizumab + gemcitabine and nab-paclitaxel
    intervention Names
    1. Drug: Epacadostat
    2. Drug: Pembrolizumab
    3. Drug: Gemcitabine
    4. Drug: nab-Paclitaxel
    label
    Treatment Group B
    type
    EXPERIMENTAL
  3. description
    Epacadostat + pembrolizumab + carboplatin and paclitaxel
    intervention Names
    1. Drug: Epacadostat
    2. Drug: Pembrolizumab
    3. Drug: Carboplatin
    4. Drug: Paclitaxel
    label
    Treatment Group C
    type
    EXPERIMENTAL
  4. description
    Epacadostat + pembrolizumab + pemetrexed and investigators choice of platinum agent
    intervention Names
    1. Drug: Epacadostat
    2. Drug: Pembrolizumab
    3. Drug: Pemetrexed
    4. Drug: Carboplatin
    5. Drug: Cisplatin
    6. Drug: Investigator's choice of platinum agent
    label
    Treatment Group D
    type
    EXPERIMENTAL
  5. description
    Epacadostat + pembrolizumab + cyclophosphamide
    intervention Names
    1. Drug: Epacadostat
    2. Drug: Pembrolizumab
    3. Drug: Cyclophosphamide
    label
    Treatment Group E
    type
    EXPERIMENTAL
  6. description
    Epacadostat + pembrolizumab + gemcitabine and investigators choice of platinum agent
    intervention Names
    1. Drug: Epacadostat
    2. Drug: Pembrolizumab
    3. Drug: Gemcitabine
    label
    Treatment Group F
    type
    EXPERIMENTAL
  7. description
    Epacadostat + pembrolizumab + investigators choice of platinum agent and 5-fluorouracil
    intervention Names
    1. Drug: Epacadostat
    2. Drug: Pembrolizumab
    3. Drug: Carboplatin
    4. Drug: Cisplatin
    5. Drug: 5-Fluorouracil
    6. Drug: Investigator's choice of platinum agent
    label
    Treatment Group G
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment Group A
    2. Treatment Group B
    3. Treatment Group C
    4. Treatment Group D
    5. Treatment Group E
    6. Treatment Group F
    7. Treatment Group G
    description
    Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
    name
    Epacadostat
    other Names
    1. INCB024360
    type
    DRUG
  2. arm Group Labels
    1. Treatment Group A
    2. Treatment Group B
    3. Treatment Group C
    4. Treatment Group D
    5. Treatment Group E
    6. Treatment Group F
    7. Treatment Group G
    description
    Pembrolizumab
    name
    Pembrolizumab
    type
    DRUG
  3. arm Group Labels
    1. Treatment Group A
    description
    Oxaliplatin
    name
    Oxaliplatin
    type
    DRUG
  4. arm Group Labels
    1. Treatment Group A
    description
    Leucovorin
    name
    Leucovorin
    type
    DRUG
  5. arm Group Labels
    1. Treatment Group A
    description
    5-Fluorouracil
    name
    5-Fluorouracil
    type
    DRUG
  6. arm Group Labels
    1. Treatment Group B
    2. Treatment Group F
    description
    Gemcitabine
    name
    Gemcitabine
    type
    DRUG
  7. arm Group Labels
    1. Treatment Group B
    description
    nab-Paclitaxel
    name
    nab-Paclitaxel
    type
    DRUG
  8. arm Group Labels
    1. Treatment Group C
    description
    Carboplatin
    name
    Carboplatin
    type
    DRUG
  9. arm Group Labels
    1. Treatment Group C
    description
    Paclitaxel
    name
    Paclitaxel
    type
    DRUG
  10. arm Group Labels
    1. Treatment Group D
    description
    Pemetrexed
    name
    Pemetrexed
    type
    DRUG
  11. arm Group Labels
    1. Treatment Group E
    description
    Cyclophosphamide
    name
    Cyclophosphamide
    type
    DRUG
  12. arm Group Labels
    1. Treatment Group D
    2. Treatment Group G
    description
    Carboplatin
    name
    Carboplatin
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
70
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of epacadostat, pembrolizumab, or chemotherapy. Serious adverse event is defined as an event that meets 1 of the following criteria: is fatal or life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, incapacity, or a substantial disruption of a person's ability to conduct normal life functions, constitutes a congenital anomaly or birth defect,is a medically important event that may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the outcomes listed above.
    measure
    Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
    time Frame
    Up to 21 months
  2. description
    A DLT was defined as the occurrence of any of the protocol-specified toxicities occurring up to and including Day 28 for the cohorts where mFOLFOX6 and nab-paclitaxel/gemcitabine are administered and Day 21 for all other chemotherapy regimens in Phase 1, except those with a clear alternative explanation (eg, disease progression) or transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination.
    measure
    Phases 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
    time Frame
    28 days
  3. description
    ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
    measure
    Phases 1 and 2: Objective Response Rate (ORR)
    time Frame
    Up to Week 18
Full study description
brief Summary
This was an open-label, nonrandomized, Phase 1/2 study designed to determine the safety, tolerability, and efficacy of epacadostat when given in combination with pembrolizumab and 7 different chemotherapy regimens described as Treatment Groups A through G below (see Study Drug and Background Therapies, Dose, and Mode of Administration). Phase 1 consisted of a 3 + 3 + 3 design intended to determine the MTD or PAD of epacadostat when given in combination with pembrolizumab and chemotherapy; efficacy was also explored. Phase 2 was designed to enroll efficacy expansion cohorts to further evaluate the safety, tolerability, and efficacy of epacadostat at the MTD or PAD (as selected in Phase 1) when given in combination with pembrolizumab and chemotherapy. Each efficacy expansion cohort was to enroll participants with 1 specific type of advanced or metastatic solid tumor. Additional cohorts (ie, the mandatory biopsy cohorts) were designed to evaluate changes in the tumor microenvironment in participants with any advanced or metastatic solid tumor who had progressed on previous therapy with a PD-1 or a PD-L1 inhibitor. No participants were enrolled in any Phase 2 efficacy expansion cohort, or in any Phase 2 mandatory biopsy cohort receiving Treatment A, B, F, or G. Phase 2 mandatory biopsy cohort participants received Treatments C, D, or E (ie, were included in Treatment Groups C, D, or E). Participants were assigned to a treatment group based on the chemotherapy regimen most appropriate for their tumor type.
Source references
references
  1. citation
    Powderly JD, Klempner SJ, Naing A, Bendell J, Garrido-Laguna I, Catenacci DVT, Taylor MH, Lee JJ, Zheng F, Zhou F, Gong X, Gowda H, Beatty GL. Epacadostat Plus Pembrolizumab and Chemotherapy for Advanced Solid Tumors: Results from the Phase I/II ECHO-207/KEYNOTE-723 Study. Oncologist. 2022 Nov 3;27(11):905-e848. doi: 10.1093/oncolo/oyac174.
    pmid
    36156099
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice