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Trial · NCT03123783

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)Phase 1b Escalation0Participants
Maximum Tolerated Dose (MTD) of APX005M + Nivolumab (Phase 1b)Phase 1b EscalationNAmg/kg
Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / GroupCohort 1 (Arm)/inNSCLC (Phase 2)16.6790% Confidence Interval 8.57 to 28.07Percentage of participants
Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / GroupCohort 2(Arm)/PD1-MM (Phase 2)15.1590% Confidence Interval 6.17 to 29.25Percentage of participants
Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / GroupCohort 3A(Arm)/PD1-NSCLC (Phase 2)0.0090% Confidence Interval 0.00 to 22.09Percentage of participants
Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / GroupCohort 3B(Arm)/PD1-NSCLC (Phase 2)0.0090% Confidence Interval 0.00 to 11.29Percentage of participants
Safety of the APX005M and Nivolumab Combination (Phase 2)Cohort 1 (Arm)/inNSCLC (Phase 2)52Participants
Safety of the APX005M and Nivolumab Combination (Phase 2)Cohort 2(Arm)/PD1-MM (Phase 2)36Participants
Safety of the APX005M and Nivolumab Combination (Phase 2)Cohort 3A(Arm)/PD1-NSCLC (Phase 2)14Participants
Safety of the APX005M and Nivolumab Combination (Phase 2)Cohort 3B(Arm)/PD1-NSCLC (Phase 2)28Participants
Duration of Response (DOR) as Per RECIST 1.1(Phase 2)Cohort 1(Arm)/inNSCLC (Phase 2)NAFull Range 3.9 to 21.4Months
Duration of Response (DOR) as Per RECIST 1.1(Phase 2)Cohort 2(Arm)/PD1-MM (Phase 2)NAFull Range 4.2 to 24.7Months
Median Progression-free Survival (PFS) (Phase 2)Cohort 1(Arm)/inNSCLC (Phase 2)4.1190% Confidence Interval 3.45 to 5.52Months
Median Progression-free Survival (PFS) (Phase 2)Cohort 2(Arm)/PD1-MM (Phase 2)1.9790% Confidence Interval 1.87 to 3.61Months
Median Progression-free Survival (PFS) (Phase 2)Cohort 3A(Arm)/PD1-NSCLC (Phase 2)3.4390% Confidence Interval 2.00 to 3.88Months
Median Progression-free Survival (PFS) (Phase 2)Cohort 3B(Arm)/PD1-NSCLC (Phase 2)3.6590% Confidence Interval 1.84 to 3.81Months
6-month PFS Rate (Phase 2)Cohort 1(Arm)/inNSCLC (Phase 2)33.1090% Confidence Interval 20.10 to 46.68Percentage of participants
6-month PFS Rate (Phase 2)Cohort 2(Arm)/PD1-MM (Phase 2)21.2190% Confidence Interval 9.35 to 36.25Percentage of participants
6-month PFS Rate (Phase 2)Cohort 3A(Arm)/PD1-NSCLC (Phase 2)25.0090% Confidence Interval 6.01 to 50.48Percentage of participants
6-month PFS Rate (Phase 2)Cohort 3B(Arm)/PD1-NSCLC (Phase 2)12.9290% Confidence Interval 3.27 to 29.41Percentage of participants

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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