Trial Outcomes & Findings for A Phase 2 Intratumoral Injection PF-3512676 Plus Local Radiation in Low-Grade B-Cell Lymphomas (NCT NCT00880581)

Last Updated: 2017-03-14

Results Overview

Overall objective response rate (OOR) at time of best response was assessed as the sum of the Complete Response (CR) rate and the Partial Response (CR, PR) rate. Response was assessed per the Cheson Criteria, as below. * Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease * CR/unconfirmed (CRu) = residual lymph node mass \>1.5 cm but regressed \>75%, with 1 residual lymph node mass \>1.5 cm that has regressed by \>75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia * Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	PF-3512676 To assess the feasibility of using intra-tumoral PF-3512676 (CpG 7909 or ProMune) at 18 mg per week over 10 weeks in combination with local radiation \[2 gray (2Gy) on each of Days 1 and 2\] as a therapy for low-grade B-cell lymphoma.
Cycle 1 STARTED	30
Cycle 1 COMPLETED	30
Cycle 1 NOT COMPLETED	0
Cycle 2 Re-treatment STARTED	24
Cycle 2 Re-treatment COMPLETED	24
Cycle 2 Re-treatment NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Intratumoral Injection PF-3512676 Plus Local Radiation in Low-Grade B-Cell Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-3512676 n=30 Participants To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 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	1 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	PF-3512676 n=30 Participants Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks. PF-3512676: 18 mg injection Local radiotherapy: 2 x 2 Gy
Overall ObjectiveResponse (ORR) Rate Complete Response (CR)	0 participants
Overall ObjectiveResponse (ORR) Rate Partial Response (PR)	7 participants
Overall ObjectiveResponse (ORR) Rate Stable Disease (SD)	19 participants
Overall ObjectiveResponse (ORR) Rate Progressive Disease (PD)	4 participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants with progressive disease (PD) were not re-evaluated.

Response after a second cycle of treatment was assessed per the Cheson Criteria, as below. * Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease * CR/unconfirmed (CRu) = residual lymph node mass \>1.5 cm but regressed \>75%, with 1 residual lymph node mass \>1.5 cm that has regressed by \>75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia * Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR.

Outcome measures

Outcome measures
Measure	PF-3512676 n=20 Participants Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks. PF-3512676: 18 mg injection Local radiotherapy: 2 x 2 Gy
Response Rate After Cycle 2 Complete Response (CR)	2 participants
Response Rate After Cycle 2 Stable Disease (SD)	14 participants
Response Rate After Cycle 2 Partial Response (PR)	4 participants

Adverse Events

PF-3512676

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PF-3512676 n=30 participants at risk Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.
Skin and subcutaneous tissue disorders erythema	56.7% 17/30 • Number of events 17
General disorders headache	20.0% 6/30 • Number of events 6
Musculoskeletal and connective tissue disorders myalgia	36.7% 11/30 • Number of events 11

Additional Information

Ronald Levy

Stanford University

Phone: 6507256452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place