Trial Outcomes & Findings for Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017 (NCT NCT03003468)

Last Updated: 2026-01-20

Results Overview

Phase Ib: Maximum tolerated dose (MTD) for subjects receiving Imprime PGG with pembrolizumab without experiencing dose-limiting toxicity(s) (DLT) per Common Terminology Criteria for Adverse Events (CTCAE) v4.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

35 participants

Primary outcome timeframe

21 days

Results posted on

2026-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Phase II: Imprime PGG 4 mg/kg Imprime PGG will be dosed at the dose established as the MTD in Phase Ib (4mg/kg) on Day 1, 8, and 15 for Cycles 1-4, and on Day 1 only for Cycles 5-16 of the 21 day cycle. Pembrolizumab will be infused at 200 mg on Day 1 of the 21 day cycle. On day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab infusion.	Phase Ib: Imprime PGG 2 mg/kg Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.	Phase Ib: Imprime PGG 4 mg/kg Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Overall Study STARTED	26	3	6
Overall Study COMPLETED	24	3	6
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase II: Imprime PGG 4 mg/kg Imprime PGG will be dosed at the dose established as the MTD in Phase Ib (4mg/kg) on Day 1, 8, and 15 for Cycles 1-4, and on Day 1 only for Cycles 5-16 of the 21 day cycle. Pembrolizumab will be infused at 200 mg on Day 1 of the 21 day cycle. On day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab infusion.	Phase Ib: Imprime PGG 2 mg/kg Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.	Phase Ib: Imprime PGG 4 mg/kg Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Overall Study Withdrawal by Subject	1	0	0
Overall Study No measurable lesions	1	0	0

Baseline Characteristics

Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase Ib: Imprime PGG 2 mg/kg n=3 Participants Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.	Phase Ib: Imprime PGG 4 mg/kg n=6 Participants Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.	Phase II: Imprime PGG 4 mg/kg n=24 Participants Imprime PGG will be dosed at the dose established as the MTD in Phase Ib (4mg/kg) on Day 1, 8, and 15 for Cycles 1-4, and on Day 1 only for Cycles 5-16 of the 21 day cycle. Pembrolizumab will be infused at 200 mg on Day 1 of the 21 day cycle. On day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab infusion.	Total n=33 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=37 Participants	1 Participants n=44 Participants	1 Participants n=40 Participants	2 Participants n=121 Participants
Age, Continuous	68 years n=37 Participants	66 years n=44 Participants	65 years n=40 Participants	66 years n=121 Participants
Sex: Female, Male Female	2 Participants n=37 Participants	5 Participants n=44 Participants	9 Participants n=40 Participants	16 Participants n=121 Participants
Sex: Female, Male Male	1 Participants n=37 Participants	1 Participants n=44 Participants	15 Participants n=40 Participants	17 Participants n=121 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=37 Participants	5 Participants n=44 Participants	23 Participants n=40 Participants	30 Participants n=121 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	1 Participants n=121 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	0 Participants n=44 Participants	2 Participants n=40 Participants	2 Participants n=121 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants	2 Participants n=44 Participants	4 Participants n=40 Participants	7 Participants n=121 Participants
Race (NIH/OMB) White	1 Participants n=37 Participants	4 Participants n=44 Participants	17 Participants n=40 Participants	22 Participants n=121 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	0 Participants n=44 Participants	1 Participants n=40 Participants	2 Participants n=121 Participants
Region of Enrollment United States	3 participants n=37 Participants	6 participants n=44 Participants	24 participants n=40 Participants	33 participants n=121 Participants
Smoking Status Never	0 Participants n=37 Participants	2 Participants n=44 Participants	3 Participants n=40 Participants	5 Participants n=121 Participants
Smoking Status Current	1 Participants n=37 Participants	0 Participants n=44 Participants	6 Participants n=40 Participants	7 Participants n=121 Participants
Smoking Status Former	2 Participants n=37 Participants	4 Participants n=44 Participants	15 Participants n=40 Participants	21 Participants n=121 Participants
ECOG Performance ECOG = 0	0 Participants n=37 Participants	0 Participants n=44 Participants	3 Participants n=40 Participants	3 Participants n=121 Participants
ECOG Performance ECOG = 1	3 Participants n=37 Participants	6 Participants n=44 Participants	20 Participants n=40 Participants	29 Participants n=121 Participants
ECOG Performance ECOG = 2	0 Participants n=37 Participants	0 Participants n=44 Participants	1 Participants n=40 Participants	1 Participants n=121 Participants

PRIMARY outcome

Timeframe: 21 days

Outcome measures

Outcome measures
Measure	Phase Ib n=9 Participants Phase Ib (Imprime PGG 2 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Phase Ib (Imprime PGG 4 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Phase Ib: Maximum Tolerated Dose Imprime PGG	4 mg
Phase Ib: Maximum Tolerated Dose Pembrolizumab	200 mg

PRIMARY outcome

Timeframe: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 32 months.

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival was defined as all patients treated at the MTD, which was determined to be Imprime PGG at 4mg/kg in combination with pembrolizumab 200mg.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Progression Free Survival (PFS) is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.

Outcome measures

Outcome measures
Measure	Phase Ib n=30 Participants Phase Ib (Imprime PGG 2 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Phase Ib (Imprime PGG 4 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Progression Free Survival	2.6 Months Interval 1.4 to 7.0

SECONDARY outcome

Timeframe: AEs have been recorded from the time of consent until 30 days after treatment discontinuation of study drugs or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months

Population: In accordance with the Statistical Analysis Plan, the analysis population for Adverse Events was defined as all patients receiving at least one dose of study treatment regardless of the dosage.

Number of participants with treatment related adverse events regardless of dose are reported by CTCAEv4 term and grade.

Outcome measures

Outcome measures
Measure	Phase Ib n=33 Participants Phase Ib (Imprime PGG 2 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Phase Ib (Imprime PGG 4 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Adverse Events (AEs) Bloating / Dyspepsia / Flatulence	1 Participants
Adverse Events (AEs) Blurred vision	1 Participants
Adverse Events (AEs) Colitis	1 Participants
Adverse Events (AEs) Creatinine increased	1 Participants
Adverse Events (AEs) Dizziness	1 Participants
Adverse Events (AEs) Dysphagia	1 Participants
Adverse Events (AEs) Fever	1 Participants
Adverse Events (AEs) Flushing	1 Participants
Adverse Events (AEs) Hyperglycemia	1 Participants
Adverse Events (AEs) Hypotension	1 Participants
Adverse Events (AEs) Movements involuntary	1 Participants
Adverse Events (AEs) Pneumonitis	1 Participants
Adverse Events (AEs) Sinus tachycardia	1 Participants
Adverse Events (AEs) Fatigue / Malaise	10 Participants
Adverse Events (AEs) Hypo / Hyperthyroidism	2 Participants
Adverse Events (AEs) Pruritus	2 Participants
Adverse Events (AEs) Allergic / Injection Site Reaction	1 Participants
Adverse Events (AEs) Anemia	1 Participants
Adverse Events (AEs) Infusion related reaction	13 Participants
Adverse Events (AEs) Arthralgia / Myalgia	7 Participants
Adverse Events (AEs) Nausea / Vomiting	7 Participants
Adverse Events (AEs) Pain	5 Participants
Adverse Events (AEs) Rash	4 Participants
Adverse Events (AEs) Chills	3 Participants
Adverse Events (AEs) Diarrhea	3 Participants
Adverse Events (AEs) Dyspnea	3 Participants
Adverse Events (AEs) Anorexia	2 Participants
Adverse Events (AEs) Cough	2 Participants
Adverse Events (AEs) Flu like symptoms	2 Participants
Adverse Events (AEs) Headache	2 Participants

SECONDARY outcome

Timeframe: Up to maximum of 32 months

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Clinical Benefit Rate was defined as all patients treated at the MTD, which was determined to be Imprime PGG at 4mg/kg in combination with pembrolizumab 200mg.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.The CBR is defined as the proportion of subjects with a confirmed complete response, partial response or stable disease based on RECIST v1.1.

Outcome measures

Outcome measures
Measure	Phase Ib n=30 Participants Phase Ib (Imprime PGG 2 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Phase Ib (Imprime PGG 4 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Clinical Benefit Rate (CBR)	47 Percentage of participants Interval 23.0 to 67.0

SECONDARY outcome

Timeframe: 6 months

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Progression Free Survival at 6 months was defined as all patients treated at the MTD, which was determined to be Imprime PGG at 4mg/kg in combination with pembrolizumab 200mg.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause. PFS at 6 months is defined as the percentage of patient who was progression free at 6 months from the initiation of treatment.

Outcome measures

Outcome measures
Measure	Phase Ib n=30 Participants Phase Ib (Imprime PGG 2 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Phase Ib (Imprime PGG 4 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Progression Free Survival (PFS) at 6 Months	37 Percentage of participants Interval 20.0 to 55.0

SECONDARY outcome

Timeframe: Time of treatment start until death or date of last contact, up to a maximum of 52 months.

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall Survival was defined as all patients treated at the MTD, which was determined to be Imprime PGG at 4mg/kg in combination with pembrolizumab 200mg.

Overall survival is defined as the time from treatment start until death or date of last contact.

Outcome measures

Outcome measures
Measure	Phase Ib n=30 Participants Phase Ib (Imprime PGG 2 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Phase Ib (Imprime PGG 4 mg/kg) : Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Overall Survival (OS)	11.1 Months Interval 7.8 to 18.0

Adverse Events

Imprime PGG 2 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Imprime PGG 4 mg/kg

Serious events: 9 serious events

Other events: 29 other events

Deaths: 21 deaths

Serious adverse events

Serious adverse events
Measure	Imprime PGG 2 mg/kg n=3 participants at risk Phase Ib (Imprime PGG 2 mg/kg): Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.	Imprime PGG 4 mg/kg n=30 participants at risk Phase Ib (Imprime PGG 4 mg/kg): Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Phase II (Imprime PGG 4 mg/kg): Imprime PGG will be dosed at the dose established as the MTD in Phase Ib (4mg/kg) on Day 1, 8, and 15 for Cycles 1-4, and on Day 1 only for Cycles 5-16 of the 21 day cycle. Pembrolizumab will be infused at 200 mg on Day 1 of the 21 day cycle. On day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab infusion.
GASTROINTESTINAL DISORDERS DIARRHEA	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	0.00% 0/30 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
GASTROINTESTINAL DISORDERS COLITIS	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	3.3% 1/30 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNEA	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	3.3% 1/30 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FEVER	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	3.3% 1/30 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS INFUSION RELATED REACTION	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	6.7% 2/30 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
GASTROINTESTINAL DISORDERS NAUSEA	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	3.3% 1/30 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
NERVOUS SYSTEM DISORDERS PERIPHERAL MOTOR NEUROPATHY	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	3.3% 1/30 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURAL EFFUSION	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	6.7% 2/30 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY FAILURE	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	3.3% 1/30 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
INFECTIONS AND INFESTATIONS SEPSIS	0.00% 0/3 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.	3.3% 1/30 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.

Other adverse events

Additional Information

Fauzia Sharmin

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place