Trial Outcomes & Findings for Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease (NCT NCT04685499)

NCT ID: NCT04685499

Last Updated: 2023-01-11

Results Overview

Examination of patients with a partial response or complete response.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

30 months

Results posted on

2023-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	Telomelysin (OBP-301) All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient. OBP-301: Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions. Pembrolizumab: Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Telomelysin (OBP-301) All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient. OBP-301: Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions. Pembrolizumab: Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year
Overall Study Study Terminated Early	1

Baseline Characteristics

Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telomelysin (OBP-301) n=1 Participants All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient. OBP-301: Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions. Pembrolizumab: Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 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	0 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	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 months

Population: Data not collected.

Examination of patients with a partial response or complete response.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 months

Population: Data not collected

We will measure the rate of grade 3 or 4 adverse events attributed to the combination of multiple intratumoral injections of OBP-301 with SBRT and pembrolizumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Examination of subjects with stable disease, a partial response, or complete response.

Outcome measures

Outcome measures
Measure	Telomelysin (OBP-301) n=1 Participants All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient. OBP-301: Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions. Pembrolizumab: Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year
Disease Control Rate, as Assessed by Radiographic Imaging Complete Response	1 Participants
Disease Control Rate, as Assessed by Radiographic Imaging Partial Response	0 Participants
Disease Control Rate, as Assessed by Radiographic Imaging Stable Disease	0 Participants

SECONDARY outcome

Timeframe: 30 months

Population: Data not collected

Defined as the time from registration to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Data not collected

Defined as the time from registration to cancer progression or death due to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Data not collected.

defined as the percentage of patients who have achieved complete response, partial response and stable disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Data not collected

Examination of subjects with stable disease, a partial response, or complete response.Immune-related disease progression (irPD) will be confirmed if the increase in tumor burden is ≥ 25% relative to nadir (minimum recorded tumor burden).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Data not collected

Examination of patients with a partial response or complete response based on RECIST 1.1 and iRECIST

Outcome measures

Outcome data not reported

Adverse Events

Telomelysin (OBP-301)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Telomelysin (OBP-301) n=1 participants at risk All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient. OBP-301: Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions. Pembrolizumab: Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year
General disorders Chills	100.0% 1/1 • Number of events 2 • The patient was followed for AEs for 13 months following initiation of treatment.
General disorders Headache	100.0% 1/1 • Number of events 3 • The patient was followed for AEs for 13 months following initiation of treatment.
General disorders Lightheadedness	100.0% 1/1 • Number of events 1 • The patient was followed for AEs for 13 months following initiation of treatment.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • The patient was followed for AEs for 13 months following initiation of treatment.
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 2 • The patient was followed for AEs for 13 months following initiation of treatment.
General disorders Diaphoresis	100.0% 1/1 • Number of events 1 • The patient was followed for AEs for 13 months following initiation of treatment.
Investigations Hyperkalemia	100.0% 1/1 • Number of events 1 • The patient was followed for AEs for 13 months following initiation of treatment.
Skin and subcutaneous tissue disorders Blister (neck)	100.0% 1/1 • Number of events 1 • The patient was followed for AEs for 13 months following initiation of treatment.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 1 • The patient was followed for AEs for 13 months following initiation of treatment.
Investigations Aspartate Aminotransferase Increase	100.0% 1/1 • Number of events 1 • The patient was followed for AEs for 13 months following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 2 • The patient was followed for AEs for 13 months following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • Number of events 1 • The patient was followed for AEs for 13 months following initiation of treatment.

Additional Information

Meyer Cancer Center GI Program Manager

Weill Cornell Medicine

Phone: 646-962-8189

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place