Trial Outcomes & Findings for Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC (NCT NCT05846646)

NCT ID: NCT05846646

Last Updated: 2025-10-20

Results Overview

Progression-free rate at 18 months

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

18 months

Results posted on

2025-10-20

Participant Flow

Study was terminated early by sponsor due to change in corporate strategy.

Participant milestones

Participant milestones
Measure	Experimental Arm (800 mcg) PULSAR-ICI + IMSA101 (800 mcg)	Experimental Arm (1200 mcg) PULSAR-ICI + IMSA101 (1200 mcg)
Overall Study STARTED	3	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Arm (800 mcg) PULSAR-ICI + IMSA101 (800 mcg)	Experimental Arm (1200 mcg) PULSAR-ICI + IMSA101 (1200 mcg)
Overall Study Physician Decision	1	0
Overall Study Lack of Efficacy	1	1
Overall Study Early Study Termination	1	2

Baseline Characteristics

Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Arm (800 mcg) n=3 Participants PULSAR-ICI + IMSA101 (800 mcg)	Experimental Arm (1200 mcg) n=3 Participants PULSAR-ICI + IMSA101 (1200 mcg)	Control Arm PULSAR - ICI	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	5 Participants n=7 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants	3 Participants n=107 Participants	0 Participants n=206 Participants	5 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=99 Participants	3 Participants n=107 Participants	0 Participants n=206 Participants	5 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Data were not collected due to study termination prior to participants' assessment at the 18-month time point

Progression-free rate at 18 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Enrolment through end of study period (1 year, 3 months). AE data captured continually.

Population: Zero patients enrolled to Control Arm during Safety Run In period.

Occurrence of treatment-related adverse events

Outcome measures

Outcome measures
Measure	Experimental Arm (800 mcg) n=3 Participants PULSAR-ICI + IMSA101 (800 mcg)	Experimental Arm (1200 mcg) n=3 Participants PULSAR-ICI + IMSA101 (1200 mcg)	Control Arm PULSAR - ICI
Number of Participants With Treatment-related Adverse Events	3 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 to 22 months

Population: Data were not collected due to study termination prior to participants' assessment at the 18-month time point

Progression-free at 8-week intervals from 6 months to 22 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: upon enrolment through end of study period (2 years)

Population: Data were not collected due to study termination prior to participants' assessment at the 18-month time point

Time to progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: upon enrolment through end of study period (2 years)

Population: Data were not collected due to study termination prior to participants' assessment at the 18-month time point

Overall response rate, duration of response, progression-free survival

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: upon enrolment through end of study period (2 years)

Population: Data were not collected due to study termination prior to participants' assessment at the 18-month time point

Patient reported outcome on FACT-G questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Experimental Arm (800 mcg)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Experimental Arm (1200 mcg)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental Arm (800 mcg) n=3 participants at risk PULSAR-ICI + IMSA101 (800 mcg)	Experimental Arm (1200 mcg) n=3 participants at risk PULSAR-ICI + IMSA101 (1200 mcg)	Control Arm PULSAR - ICI
Infections and infestations Possible Sepsis	33.3% 1/3 • Number of events 1 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Respiratory, thoracic and mediastinal disorders Pneumonia	33.3% 1/3 • Number of events 1 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Number of events 1 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.

Other adverse events

Additional Information

Patrick Widhelm, Senior Director Clinical Operations and Project Management

ImmuneSensor Therapeutics, Inc.

Phone: 830-730-8176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Experimental Arm (800 mcg) n=3 participants at risk PULSAR-ICI + IMSA101 (800 mcg)	Experimental Arm (1200 mcg) n=3 participants at risk PULSAR-ICI + IMSA101 (1200 mcg)	Control Arm PULSAR - ICI
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Gastrointestinal disorders Nausea	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
General disorders Chills	100.0% 3/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
General disorders Fatigue	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	100.0% 3/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
General disorders Non-cardiac chest pain	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
General disorders Pain	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
General disorders Pyrexia	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Investigations Weight decreased	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Investigations Decreased Appetite	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Nervous system disorders Dizziness	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Respiratory, thoracic and mediastinal disorders Pneumonitis	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	66.7% 2/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	33.3% 1/3 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.	— 0/0 • Enrolment through end of study period (1 year, 3 months). AE data captured continually. Analysis population is the six patients enrolled to the Experimental Arm.