Trial Outcomes & Findings for Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer (NCT NCT03325816)
NCT ID: NCT03325816
Last Updated: 2021-03-16
Results Overview
Maximum tolerated dose of 177Lu-DOTA0-Tyr3-Octreotate as determined during the phase I portion.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
12 months
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
Phase I - Dose Level -1
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
Phase I - Dose Level 0
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase I - Dose Level -1
n=3 Participants
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
Phase I - Dose Level 0
n=6 Participants
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsMaximum tolerated dose of 177Lu-DOTA0-Tyr3-Octreotate as determined during the phase I portion.
Outcome measures
| Measure |
Phase I
n=9 Participants
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 or 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
Phase I - Dose Level 0
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
|---|---|---|
|
Phase I - Recommended Phase II Dose (RP2D) of 177Lu-DOTA0-Tyr3-Octreotate
|
7.4 GBq
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision.
Time between start of treatment and tumor progression or death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsAdverse events and serious adverse events experienced by subjects
Outcome measures
| Measure |
Phase I
n=3 Participants
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 or 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
Phase I - Dose Level 0
n=6 Participants
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
|---|---|---|
|
Number of Participants With Treatment Related Adverse Events
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision.
Time between start of treatment and death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision.
The percentage of patients who achieve complete response, partial response and stable disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision.
The proportion of patients with tumor size reduction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision.
As measured by NETSPOT PET scan
Outcome measures
Outcome data not reported
Adverse Events
Phase I - Dose Level -1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I - Dose Level 0
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I - Dose Level -1
n=3 participants at risk
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
Phase I - Dose Level 0
n=6 participants at risk
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
|---|---|---|
|
Cardiac disorders
Ventricular Tachycardia
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Infections and infestations
Biliary Tract Infection
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Phase I - Dose Level -1
n=3 participants at risk
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
Phase I - Dose Level 0
n=6 participants at risk
Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • Number of events 1 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • 24 months
|
33.3%
2/6 • Number of events 2 • 24 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • 24 months
|
33.3%
2/6 • Number of events 4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 2 • 24 months
|
33.3%
2/6 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Infections and infestations
Bronchial Infection
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 24 months
|
33.3%
2/6 • Number of events 3 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 24 months
|
33.3%
2/6 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
General disorders
Edema Limbs
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • Number of events 1 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 2 • 24 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 24 months
|
33.3%
2/6 • Number of events 2 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • 24 months
|
33.3%
2/6 • Number of events 2 • 24 months
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 3 • 24 months
|
33.3%
2/6 • Number of events 4 • 24 months
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 24 months
|
50.0%
3/6 • Number of events 4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
33.3%
1/3 • Number of events 1 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 24 months
|
33.3%
2/6 • Number of events 4 • 24 months
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 2 • 24 months
|
0.00%
0/6 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • 24 months
|
66.7%
4/6 • Number of events 6 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Urinary tract pain
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Cardiac disorders
Ventricular tachycardia
|
33.3%
1/3 • Number of events 1 • 24 months
|
0.00%
0/6 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 24 months
|
33.3%
2/6 • Number of events 3 • 24 months
|
|
Investigations
Weight Loss
|
33.3%
1/3 • Number of events 1 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
|
General disorders
General disorders and administration site conditions Other, specify
|
0.00%
0/3 • 24 months
|
16.7%
1/6 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place