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NCT01928394 · OUTCOME

Objective Response Rate ( ORR )

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
60 months

What was measured

The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.

Analysis population: All Treated Participants

Groups in this outcome

TNBC Arm N

Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W

TNBC Arm N-I Dose Level 1

Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

TNBC Arm N-I Dose Level 2

Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

GC Arm N

Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W

GC Arm N-I Dose Level 1

Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

GC Arm N-I Dose Level 2

Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W

GC Arm N-I Dose Level 2b

Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

PC Arm N

Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W

PC Arm N-I Dose Level 1

Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

PC Arm N-I Dose Level 2

Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

PC Arm N-I Dose Level 2d

Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off

SCLC Arm N - Pre-expansion

Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W

SCLC Arm N-I Dose Level 2 - Pre-expansion

Small cell lung cancer (SCLC) treated participants in Pre-expansion cohort treated with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

SCLC Arm N Expansion

Small cell lung cancer (SCLC) expansion cohort participants:Nivolumab monotherapy (3 mg/kg) Q2W

SCLC Arm N-I Dose Level 2- Expansion

Small cell lung cancer (SCLC) expansion cohort participants Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi

SCLC Arm N-I Dose Level 1 -

Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W

SCLC Arm N-I Dose Level 2b

Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

SCLC Arm N- All Treated

Small cell lung cancer (SCLC) for all treated participants with Nivolumab 3 mg/kg Q2W

SCLC Arm N-I Dose Level 2 - All Treated

Small cell lung cancer (SCLC) all treated participants with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses

BC Arm N

Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W

BC Arm N-I Dose Level 2

Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

BC Arm N-I Dose Level 2b

Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

OC Arm N-I Dose Level 2

Ovarian cancer (OC) participants: Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

OC Arm N-I Dose Level 2b:

Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W

OC Arm N-I Dose Level 2c:

Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W

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

Analysis denominator · Participants

GroupSource count
TNBC Arm N18
TNBC Arm N-I Dose Level 13
TNBC Arm N-I Dose Level 218
GC Arm N59
GC Arm N-I Dose Level 13
GC Arm N-I Dose Level 249
GC Arm N-I Dose Level 2b52
PC Arm N18
PC Arm N-I Dose Level 13
PC Arm N-I Dose Level 218
PC Arm N-I Dose Level 2d30
SCLC Arm N - Pre-expansion98
SCLC Arm N-I Dose Level 2 - Pre-expansion61
SCLC Arm N Expansion147
SCLC Arm N-I Dose Level 2- Expansion96
SCLC Arm N-I Dose Level 1 -3
SCLC Arm N-I Dose Level 2b55
SCLC Arm N- All Treated245
SCLC Arm N-I Dose Level 2 - All Treated157
BC Arm N78
BC Arm N-I Dose Level 292
BC Arm N-I Dose Level 2b104
OC Arm N-I Dose Level 241
OC Arm N-I Dose Level 2b:43
OC Arm N-I Dose Level 2c:42

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TNBC Arm N5.6Not reported0.127.3Not reported
TNBC Arm N-I Dose Level 10.0Not reported0.070.8Not reported
TNBC Arm N-I Dose Level 20.0Not reported0.018.5Not reported
GC Arm N11.9Not reported4.922.9Not reported
GC Arm N-I Dose Level 10.0Not reported0.070.8Not reported
GC Arm N-I Dose Level 224.5Not reported13.338.9Not reported
GC Arm N-I Dose Level 2b7.7Not reported2.118.5Not reported
PC Arm N0.0Not reported018.5Not reported
PC Arm N-I Dose Level 10.0Not reported0.070.8Not reported
PC Arm N-I Dose Level 20.0Not reported0.018.5Not reported
PC Arm N-I Dose Level 2d6.7Not reported0.822.1Not reported
SCLC Arm N - Pre-expansion13.3Not reported7.321.6Not reported
SCLC Arm N-I Dose Level 2 - Pre-expansion26.2Not reported15.839.1Not reported
SCLC Arm N Expansion11.6Not reported6.917.9Not reported
SCLC Arm N-I Dose Level 2- Expansion21.9Not reported14.131.5Not reported
SCLC Arm N-I Dose Level 1 -33.3Not reported0.890.6Not reported
SCLC Arm N-I Dose Level 2b18.2Not reported9.130.9Not reported
SCLC Arm N- All Treated11.8Not reported8.116.6Not reported
SCLC Arm N-I Dose Level 2 - All Treated22.3Not reported16.029.6Not reported
BC Arm N25.6Not reported16.436.8Not reported
BC Arm N-I Dose Level 238.0Not reported28.148.8Not reported
BC Arm N-I Dose Level 2b26.9Not reported18.736.5Not reported
OC Arm N-I Dose Level 212.2Not reported4.126.2Not reported
OC Arm N-I Dose Level 2b:7.0Not reported1.519.1Not reported
OC Arm N-I Dose Level 2c:9.5Not reported2.722.6Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.26
    group Description
    SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion
    group Ids
    1. OG013
    2. OG014
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0309
    param Type
    Odds Ratio (OR)
    param Value
    2.12
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.26
    group Description
    SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion
    group Ids
    1. OG013
    2. OG014
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0309
    param Type
    Odds Ratio (OR)
    param Value
    2.12
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        27.3
        value
        5.6
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        18.5
        value
        0.0
      4. group Id
        OG003
        lower Limit
        4.9
        upper Limit
        22.9
        value
        11.9
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0.0
      6. group Id
        OG005
        lower Limit
        13.3
        upper Limit
        38.9
        value
        24.5
      7. group Id
        OG006
        lower Limit
        2.1
        upper Limit
        18.5
        value
        7.7
      8. group Id
        OG007
        lower Limit
        0
        upper Limit
        18.5
        value
        0.0
      9. group Id
        OG008
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0.0
      10. group Id
        OG009
        lower Limit
        0.0
        upper Limit
        18.5
        value
        0.0
      11. group Id
        OG010
        lower Limit
        0.8
        upper Limit
        22.1
        value
        6.7
      12. group Id
        OG011
        lower Limit
        7.3
        upper Limit
        21.6
        value
        13.3
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      18
    4. group Id
      OG003
      value
      59
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      49
    7. group Id
      OG006
      value
      52
    8. group Id
      OG007
      value
      18
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      18
    11. group Id
      OG010
      value
      30
    12. group Id
      OG011
      value
      98
    units
    Participants
description
The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
dispersion Type
95% Confidence Interval
groups
  1. description
    Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W
    id
    OG000
    title
    TNBC Arm N
  2. description
    Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
    id
    OG001
    title
    TNBC Arm N-I Dose Level 1
  3. description
    Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
    id
    OG002
    title
    TNBC Arm N-I Dose Level 2
  4. description
    Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W
    id
    OG003
    title
    GC Arm N
  5. description
    Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
    id
    OG004
    title
    GC Arm N-I Dose Level 1
  6. description
    Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W
    id
    OG005
    title
    GC Arm N-I Dose Level 2
  7. description
    Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
    id
    OG006
    title
    GC Arm N-I Dose Level 2b
  8. description
    Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W
    id
    OG007
    title
    PC Arm N
  9. description
    Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
    id
    OG008
    title
    PC Arm N-I Dose Level 1
  10. description
    Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
    id
    OG009
    title
    PC Arm N-I Dose Level 2
  11. description
    Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off
    id
    OG010
    title
    PC Arm N-I Dose Level 2d
  12. description
    Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W
    id
    OG011
    title
    SCLC Arm N - Pre-expansion
param Type
NUMBER
population Description
All Treated Participants
reporting Status
POSTED
time Frame
60 months
title
Objective Response Rate ( ORR )
type
PRIMARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice