Trial Outcomes & Findings for Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma (NCT NCT03035331)

Last Updated: 2025-05-16

Results Overview

Maximum tolerated dose (MTD) will be defined as the dose level that does not induce dose limiting toxicity in at least one-third of patients. DLTs are defined as Grade 4 or 5 ANC or PLT for at least 7 days, grade 3 plus Infections and infestations, febrile neutropenia defined as fever ≥38.5oC (38 \>1 hour) with grade 4 plus neutropenia, at least Grade 3 erythema multiforme, ulceration, or urticaria that does not resolve to Grade 2 or less within \> three weeks, at least grade 3 bronchial obstruction, pneumonitis, or wheezing at least grade 3 allergic reaction or autoimmunity at least grade 3 that does not resolve to less than Grade 2\> less than or equal to 72 hours per NCI Common Terminology Criteria for Adverse Events.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

56 days

Results posted on

2025-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 Dose Level 1 Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	3	8
Overall Study COMPLETED	3	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=8 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Total n=11 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	64 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 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	8 Participants n=7 Participants	11 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	8 Participants n=7 Participants	11 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: 56 days

Population: All eligible and treated phase 1 patients are included.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Number of Patients That Experienced a Dose Limiting Toxicity (DLT)	0 Participants	—

PRIMARY outcome

Timeframe: 24 months

The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=8 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Percentage of Complete Responses of Combination Therapy With Pembrolizumab, Cryoablation, and Intra-tumor Injection of Autologous Dendritic Cells (DC) at Maximum Tolerated Dose (MTD) Dose	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: 24 months

The distribution of survival time will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=8 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Progression Free Survival	5 Months Interval 3.8 to Not enough events occurred to calculate the upper confidence interval.	3.6 Months Interval 2.9 to Not enough events occurred to calculate the upper confidence interval.

SECONDARY outcome

Timeframe: 34 months

The distribution of treatment-free survival will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=1 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Treatment Free Survival	15.8 months Not enough events to calculate the confidence interval.	18.1 months Interval 5.2 to Not enough events to calculate the upper confidence interval.

SECONDARY outcome

Timeframe: 11 months

Population: Both phases were combined per protocol for this analysis. Only patients that achieved a response are included in this analysis.

The distribution of duration of complete response will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=4 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Duration of Response	6 months Interval 1.4 to Not enough events to calculate the upper confidence interval.	—

SECONDARY outcome

Timeframe: 2 years

The percentage of patients without disease at two years post start of treatment.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=8 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Disease Free Survival Rate	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: 5 years

The distribution of survival time will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=8 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Overall Survival	NA months Interval 3.8 to Not enough events to calculate the median or upper confidence interval.	NA months Interval 3.6 to Not enough events to calculate the median or upper confidence interval.

SECONDARY outcome

Timeframe: Up to 4 years

Will be assessed by Common Terminology Criteria for Adverse Events version 4.0.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=8 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Percentage of Patients With Grade 4 or 5 Adverse Events	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: 4 years

Will be measured using the Functional Assessment of Cancer Therapy-lymphoma. The assessment will be scored according to the scoring algorithm. Changes from baseline will be calculated at each assessment time points. Mean change scores at each time point will be calculated to determine if quality of life is reduced over the course of treatment. Longitudinal techniques will be employed to describe changes over time.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=7 Participants Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Percent of Patients With Improved Quality of Life	33.3 percentage of participants	57.14 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 years

Measurements of index lesion(s) (non-cryoablated lesion) will be evaluated over time for each patient as a marker of systemic immune and treatment response to pembrolizumab and localized treatment with cryoablation and dendritic cell therapy. The index lesion(s) will be selected by the treating physician/investigator and are noncryoablated node. The percent change from baseline in index lesion measurements will be assessed over time. Differences in values over time will be summarized descriptively and graphically. The whole body computed tomography (CT) or positron emission tomography/CT will be used to assess overall clinical response and time to progression using the standard Cheson criteria.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 4 years

Will be evaluated and summarized both quantitatively and graphically. Each of the correlative endpoints will be summarized individually, but will also be evaluated in terms of their relationships to one another; i.e., will use Spearman rank correlation coefficient to assess the correlations between baseline levels as well as between changes before and after treatment in these immunologic markers. In addition, these immunologic markers will be correlated with cancer and treatment- related outcomes (e.g. response, toxicities). Relationships will also be explored graphically using scatter plots.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1 Dose Level 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 2 Dose Level 1

Serious events: 2 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 Dose Level 1 n=3 participants at risk Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=8 participants at risk Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Infections and infestations Lung infection	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.

Other adverse events

Additional Information

Yi Lin

Mayo Clinic

Phone: 507-293-5189

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase 1 Dose Level 1 n=3 participants at risk Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.	Phase 2 Dose Level 1 n=8 participants at risk Patients receive 200mg pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive an injection of between 30-60 million dendritic cells on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Number of events 15 • Adverse events time frame was 4 years, mortality time frame was 5 years.	87.5% 7/8 • Number of events 39 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	25.0% 2/8 • Number of events 7 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Gastrointestinal disorders Constipation	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Gastrointestinal disorders Diarrhea	100.0% 3/3 • Number of events 7 • Adverse events time frame was 4 years, mortality time frame was 5 years.	62.5% 5/8 • Number of events 21 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 2 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Adverse events time frame was 4 years, mortality time frame was 5 years.	37.5% 3/8 • Number of events 17 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.	25.0% 2/8 • Number of events 4 • Adverse events time frame was 4 years, mortality time frame was 5 years.
General disorders Chills	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.
General disorders Fatigue	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	25.0% 2/8 • Number of events 7 • Adverse events time frame was 4 years, mortality time frame was 5 years.
General disorders Pain	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	25.0% 2/8 • Number of events 3 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Infections and infestations Infections and infestations - Oth spec	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 2 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Infections and infestations Lung infection	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Infections and infestations Urinary tract infection	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 2 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Investigations Lymphocyte count decreased	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	50.0% 4/8 • Number of events 6 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Investigations Neutrophil count decreased	66.7% 2/3 • Number of events 4 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 4 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 18 • Adverse events time frame was 4 years, mortality time frame was 5 years.	37.5% 3/8 • Number of events 7 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Investigations White blood cell decreased	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 4 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 2 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Nervous system disorders Headache	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 2 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Nervous system disorders Paresthesia	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Psychiatric disorders Depression	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 3 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 2/3 • Number of events 7 • Adverse events time frame was 4 years, mortality time frame was 5 years.	25.0% 2/8 • Number of events 11 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 4 • Adverse events time frame was 4 years, mortality time frame was 5 years.	25.0% 2/8 • Number of events 9 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse events time frame was 4 years, mortality time frame was 5 years.	12.5% 1/8 • Number of events 1 • Adverse events time frame was 4 years, mortality time frame was 5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 16 • Adverse events time frame was 4 years, mortality time frame was 5 years.	50.0% 4/8 • Number of events 21 • Adverse events time frame was 4 years, mortality time frame was 5 years.