Trial Outcomes & Findings for A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) (NCT NCT05577715)
NCT ID: NCT05577715
Last Updated: 2025-09-04
Results Overview
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
TERMINATED
PHASE2
31 participants
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
2025-09-04
Participant Flow
Participant milestones
| Measure |
MORAb-202 25mg/m^2
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
MORAb-202 25mg/m^2
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
STUDY TERMINATED BY SPONSOR
|
16
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
6
|
Baseline Characteristics
A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)
Baseline characteristics by cohort
| Measure |
MORAb-202 25mg/m^2
n=31 Participants
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)Population: All Randomized Participants
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
MORAb-202 25mg/m^2
n=31 Participants
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Objective Response Rate as Per Investigator
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
PRIMARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (up to approximately 12 months).Population: All Treated Participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
MORAb-202 25mg/m^2
n=31 Participants
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Number of Participants With Drug -Related Adverse Events Leading to Discontinuation
|
3 Participants
|
SECONDARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (up to approximately 12 months).Population: All Treated Participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Serious adverse events (SAE) are defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death).
Outcome measures
| Measure |
MORAb-202 25mg/m^2
n=31 Participants
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Adverse Events Grade 1
|
10 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Adverse Events Grade 2
|
5 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Adverse Events Grade 3
|
3 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Adverse Events Grade 4
|
0 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Adverse Events Grade 5
|
0 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Serious Adverse Events (Any Grade)
|
7 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Serious Adverse Events (Grade 3/4)
|
7 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Serious Adverse Events Grade 5
|
1 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Drug related SAEs Any Grade
|
2 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Drug related SAEs Grade 3-4
|
2 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Drug related SAEs Grade 5
|
0 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Drug related AEs Grade 1
|
10 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Drug related AEs Grade 2
|
5 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Drug related AEs Grade 3
|
3 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Drug related AEs Grade 4
|
0 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Drug related AEs Grade 5
|
0 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
AESI - Pneumonitis
|
2 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
AESI - Bronchospasm
|
1 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Infusion related reaction
|
1 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Deaths
|
7 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Lymphocytes (ABSOLUTE) Grade 3
|
1 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Creatinine - Grade 3
|
2 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)Population: All Randomized Participants
Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) divided by the number of all randomized participants. per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
MORAb-202 25mg/m^2
n=31 Participants
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Disease Control Rate as Per Investigator
|
67.7 percentage of participants
Interval 48.6 to 83.3
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)Population: All Randomized Participants. Only responders (CR or PR) were analyzed.
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
MORAb-202 25mg/m^2
n=3 Participants
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Duration of Response as Per Investigator
|
NA months
Not estimated due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)Population: All Randomized Participants
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
MORAb-202 25mg/m^2
n=31 Participants
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Progression Free-Survival as Per Investigator
|
3.52 months
Interval 2.6 to 5.42
|
Adverse Events
MORAb-202 25mg/m^2
Serious adverse events
| Measure |
MORAb-202 25mg/m^2
n=31 participants at risk
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Investigations
Blood creatinine increased
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Nervous system disorders
Syncope
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.2%
1/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
Other adverse events
| Measure |
MORAb-202 25mg/m^2
n=31 participants at risk
Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m\^2 intravenous infusion once every 3 weeks (Q3W).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.9%
4/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.7%
3/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
3/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
General disorders
Asthenia
|
19.4%
6/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
General disorders
Fatigue
|
12.9%
4/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
General disorders
Non-cardiac chest pain
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
General disorders
Pyrexia
|
9.7%
3/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
12.9%
4/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Infections and infestations
Urinary tract infection
|
9.7%
3/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Investigations
Blood creatine phosphokinase increased
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Investigations
Blood creatinine increased
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.7%
3/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
3/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Nervous system disorders
Paraesthesia
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Renal and urinary disorders
Proteinuria
|
9.7%
3/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.7%
12/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.9%
4/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
2/31 • All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER