- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441337
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies (MDX1106-01)
February 5, 2015 updated by: Bristol-Myers Squibb
A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Six patients enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the dose-escalation portion of the study.
Patients who respond may receive additional doses of drug.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Johns Hopkins Unv., School of Medicine
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Health System
-
-
Missouri
-
St. Louis, Missouri, United States, 63110
- Washington University School of Medicine - Barnes Jewish Hospital
-
-
North Carolina
-
Huntersville, North Carolina, United States, 28078
- Carolina BioOncology Institute, PLLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 0.3 mg/kg MDX-1106 drug
0.3 milligrams (mg) MDX-1106 drug (nivolumab) per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion.
If criteria were met, 2 additional doses could be administered (1 every 4 weeks).
|
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
Other Names:
|
EXPERIMENTAL: 1 mg/kg MDX-1106 drug
1 mg MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion.
If criteria were met, 2 additional doses could be administered (1 every 4 weeks).
|
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
Other Names:
|
EXPERIMENTAL: 3 mg/kg MDX-1106 drug
3 mgs MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion.
If criteria were met, 2 additional doses could be administered (1 every 4 weeks).
|
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
Other Names:
|
EXPERIMENTAL: 10 mg/kg MDX-1106 drug
10 mgs MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion.
If criteria were met, 2 additional doses could be administered (1 every 4 weeks).
|
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation
|
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.
Severe=All Grade 3 or 4 events.
Death=during the study and up to 28 days past study discontinuation.
AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon.
DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.
|
Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation
|
Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose
Time Frame: Day 1 to Day 85
|
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method.
For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85.
The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).
|
Day 1 to Day 85
|
Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose
Time Frame: Day 1 to Day 85
|
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method.
For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85.
The PK parameter of Tmax was measured in hours (h).
|
Day 1 to Day 85
|
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
Time Frame: Day 1 to Day 85
|
AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation.
AUC(INF): Area under the curve from the time of dosing extrapolated to infinity.
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method.
For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85.
The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms*hours per milliliter (µg*h/mL).
|
Day 1 to Day 85
|
Mean Elimination Half-life (T-HALF) Post-Single Dose
Time Frame: Day 1 to Day 85
|
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method.
For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85.
The PK parameter of T-HALF was measured in days.
|
Day 1 to Day 85
|
Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose
Time Frame: Day 1 to Day 85
|
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method.
For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85.
The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg).
|
Day 1 to Day 85
|
Mean Volume of Distribution (Vz) Post-Single Dose
Time Frame: Day 1 to Day 85
|
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method.
For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85.
The PK parameter of Vz was measured in milliliters per kilogram of body weight (mL/kg).
|
Day 1 to Day 85
|
Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population
Time Frame: Day 1 up to 2 Years.
|
The Best Overall Response Rate (BORR) was defined as the number of participants who had a confirmed complete response (CR) or partial response (PR) during the study divided by the total number of participants evaluated.
Response was based on tumor assessment for both target and non-target lesions using: Clinical examination; Chest X-ray; Computed Tomography and Magnetic Resonance Imaging; Bone scan; Ultrasound.
Per National Cancer Institute Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, best overall response (BOR) for tumors was confirmed CR or PR.
CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter.
Confidence intervals (CIs) were computed using the Clopper and Pearson method.
|
Day 1 up to 2 Years.
|
Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC)
Time Frame: Day 1 to Day 85
|
The PSA response rate was defined as the number of participants who had at least a 50% decrease of the PSA value from the PSA reference value divided by the total number of participants evaluated (percent of participants).
PSA reference value was the PSA concentration measured immediately prior to dosing on Day 1. PSA response was assessed using the Recommendations from the National Cancer Institute Prostate-Specific Antigen Working Group.
A PSA response had to be confirmed at least 4 weeks after first response.
95% exact CIs were computed using the Clopper and Pearson method.
|
Day 1 to Day 85
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Best Overall Response (BOR) by Category in Safety Population
Time Frame: Day 1 to Day 85
|
Measurable and non-measurable disease/target lesions were evaluated according to National Cancer Institute standardized RECIST.Complete Response (CR)=disappearance of all target and non-target lesions and no new lesions; Partial Response=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; Stable disease (SD)=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since treatment; PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions.
BOR was recorded between the first tumor assessment and last tumor assessment.
CR and PR had to be confirmed by repeat assessment no less than 4 weeks after the criteria were first met.
SD assessment must have met the criteria at least once at or after Week 12.
|
Day 1 to Day 85
|
Percentage of Participants With Disease Control and Major Durable Disease Control
Time Frame: Day 1 to 2 Years
|
Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants.
Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants.
Per RECIST v 1.0, BOR for tumors was confirmed CR or PR.
CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD.
PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions.
95% CIs were computed using the Clopper and Pearson method.
|
Day 1 to 2 Years
|
Median Time to Tumor Response and Duration of Tumor Response
Time Frame: Day 1 to 2 Years
|
Time to tumor response: from the date of first dose to the first date of tumor response (CR or PR confirmed at least 4 weeks later); for nonresponders, it was censored at the date of the maximum tumor assessment time in the dose cohort by the end of study.
Duration of tumor response was calculated from the first date of response of CR or PR to the date of the first PD or the date of death if a participant died due to disease progression (whichever occurred first).
Duration of response was censored at the last tumor assessment date by the end of study if a responder did not have PD or death.
Nonresponders had the duration of response as an event of 0 days.
|
Day 1 to 2 Years
|
Time to Tumor Progression and Tumor Progression Free Survival
Time Frame: Day 1 to 2 Years
|
Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD.
For those who died without PD it was censored at the date of death.
TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death.
Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death.
PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death.
|
Day 1 to 2 Years
|
Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population
Time Frame: Day 1 to 2 Years
|
Time to PSA progression: first dose to first PSA progression.
Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment.
PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first.
Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment.
CI computed using Brookmeyer and Crowley method.
|
Day 1 to 2 Years
|
Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population
Time Frame: Day 29, Day 57, Day 85
|
PSA relative velocity (PSA RV) was defined as = (d[PSA]/dt)/ [PSA], where [PSA] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level.
Decreases in PSA RV may occur while measured [PSA] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature.
Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement.
|
Day 29, Day 57, Day 85
|
Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population
Time Frame: Baseline, Day 2, Day 85, Day 113
|
12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle).
In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment.
Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available.
PR, QRS and QT interval were measured in milliseconds (msec).
|
Baseline, Day 2, Day 85, Day 113
|
Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population
Time Frame: Baseline, Day 1
|
Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated.
Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion.
Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available.
Mean DBP on Day 1 for first dose (cycle 1) are presented below.
|
Baseline, Day 1
|
Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population
Time Frame: Baseline, Day 1
|
Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated.
Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion.
Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available.
Mean SBP on Day 1 for first dose (cycle 1) are presented below.
|
Baseline, Day 1
|
Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population
Time Frame: Baseline, Day 1
|
Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated.
Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion.
Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available.
Mean DBP on Day 1 for first dose (cycle 1) are presented below.
|
Baseline, Day 1
|
Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population
Time Frame: Baseline, Day 1
|
Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated.
Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion.
Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available.
Mean SBPs on Day 1 for first dose (cycle 1) are presented below.
|
Baseline, Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (ACTUAL)
November 1, 2009
Study Completion (ACTUAL)
November 1, 2009
Study Registration Dates
First Submitted
February 27, 2007
First Submitted That Met QC Criteria
February 27, 2007
First Posted (ESTIMATE)
February 28, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
February 20, 2015
Last Update Submitted That Met QC Criteria
February 5, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genital Neoplasms, Male
- Prostatic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Neoplasms
- Neuroendocrine Tumors
- Nevi and Melanomas
- Neoplasms
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Prostatic Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Colorectal Neoplasms
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
Other Study ID Numbers
- CA209-001 ST
- MDX1106-01 (OTHER: BMS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Non-Small-Cell Lung
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
-
National Cancer Institute (NCI)Active, not recruitingLung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Puerto Rico
-
National Cancer Institute (NCI)Active, not recruitingStage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
Clinical Trials on MDX-1106
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHepatocellular Carcinoma | Resectable Hepatocellular CarcinomaUnited States
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of... and other collaboratorsActive, not recruitingPathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC v8United States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Bristol-Myers SquibbCompletedClear Cell Renal Cell CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Uveal Melanoma | Stage IV Uveal Melanoma AJCC v7United States
-
Jonsson Comprehensive Cancer CenterBristol-Myers SquibbCompletedGastrointestinal Stromal TumorUnited States
-
Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI)TerminatedStage IV Breast Cancer | HER2/Neu Negative | Recurrent Inflammatory Breast Carcinoma | Stage IV Inflammatory Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Kidney Medullary Carcinoma | Loss of INI 1 Protein ExpressionUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Bristol-Myers SquibbTerminatedSolid Tumors Induced by Prior Radiation ExposureUnited States
-
Bristol-Myers SquibbActive, not recruitingAdvanced or Metastatic Solid TumorsUnited States, Germany, Spain, United Kingdom, Italy, Canada, Denmark, Finland
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMyelodysplastic Syndrome | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Allogeneic Hematopoietic Stem Cell Transplantation RecipientUnited States