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NCT02554812 · OUTCOME

Phase 1b Lead-in: Number of Participants With First Cycle DLT for Combination F

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to first Cycle (up to 4 weeks)

What was measured

Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.

Analysis population: The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first cycle (1 cycle = 4 weeks) or completed observation period for the first cycle of treatment. Here, "N''=number of participants evaluable for this outcome measure.

Groups in this outcome

Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.

Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.

Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab6
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg6
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab1Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg1Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.
groups
  1. description
    During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
    id
    OG000
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
  2. description
    During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
    id
    OG001
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
  3. description
    During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
    id
    OG002
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first cycle (1 cycle = 4 weeks) or completed observation period for the first cycle of treatment. Here, "N''=number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline up to first Cycle (up to 4 weeks)
title
Phase 1b Lead-in: Number of Participants With First Cycle DLT for Combination F
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice