Phase 1
N=39
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
Carcinoma, Non-Small-Cell Lung · Colorectal Cancer · Malignant Melanoma · Renal Cancer · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00441337 ↗Enrolled (actual)
39
Serious AEs
59.0%
Results posted
Feb 2015
Primary outcome: Primary: Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population — 5; 5; 4; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MDX-1106 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population |
5; 5; 4; 18; 3; 5 | — |
| PRIMARY Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose |
6.7; 16.0; 60.0; 196.3 | — |
| PRIMARY Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose |
3.0; 1.9; 3.1; 1.6 | — |
| PRIMARY Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose |
970; 3244; 13909; 55324; 2343; 6014 | — |
| PRIMARY Mean Elimination Half-life (T-HALF) Post-Single Dose |
18.9; 17.0; 17.0; 24.8 | — |
| PRIMARY Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose |
0.13; 0.17; 0.19; 0.13 | — |
| PRIMARY Mean Volume of Distribution (Vz) Post-Single Dose |
82.8; 99.6; 112.7; 109.4 | — |
| PRIMARY Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population |
0; 0; 16.7; 9.5; 0; 0 | — |
| PRIMARY Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC) |
0; 0; 0 | — |
| SECONDARY Number of Participants With Best Overall Response (BOR) by Category in Safety Population |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Disease Control and Major Durable Disease Control |
16.7; 16.7; 50.0; 38.1; 0; 16.7 | — |
| SECONDARY Median Time to Tumor Response and Duration of Tumor Response |
57; 386; 796; 327 | — |
| SECONDARY Time to Tumor Progression and Tumor Progression Free Survival |
56; 57.5; 86; 57; 56; 57.5 | — |
| SECONDARY Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population |
29; 58.5; 29; 29; 58.5; 29 | — |
| SECONDARY Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population |
0.009; -0.007; -0.015; 0.003; -0.009; 0.001 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population |
7.3; -9.7; -1.7; -0.3; 5.0; -2.0 | — |
| SECONDARY Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population |
80.3; 82.4; 87.0; 81.0; 79.8; 80.3 | — |
| SECONDARY Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population |
141.8; 144.2; 154.3; 140.3; 147.5; 141.0 | — |
| SECONDARY Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population |
80.3; 72.2; 74.4; 79.2; 73.6; 74.2 | — |
| SECONDARY Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population |
133.2; 121.3; 128.8; 138.8; 116.4; 129.5 | — |
Summary
To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer
Eligibility Criteria
Inclusion Criteria
- Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma
- Prior treatment must have been completed at least 4 weeks prior to enrollment
- No untreated primary or metastatic brain or meningeal tumors
- ECOG PS 0 or 1
- Meet all screening laboratory values
Exclusion Criteria
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Active autoimmune disease or a documented history of autoimmune disease
- Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
- Active infection
- Concurrent medical condition requiring the use of immunosuppressive medications
Data sourced from ClinicalTrials.gov (NCT00441337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.