Trial Outcomes & Findings for Pembrolizumab With Rituximab or Obinutuzumab in Treating Patients With Relapsed or Refractory Follicular Lymphoma or Diffuse Large B Cell Lymphoma (NCT NCT03401853)

NCT ID: NCT03401853

Last Updated: 2025-07-22

Results Overview

Will be defined as the rate of complete + partial responses using computed tomography (CT) criteria (Lugano 2014).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Up to 90 days after the last dose of pembrolizumab

Results posted on

2025-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) INDUCTION: Patients diagnosed with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm II DLBCL (Pembrolizumab, Rituximab) INDUCTION: Patients diagnosed with R/R DLBCL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) INDUCTION: Patients diagnosed with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Obinutuzumab: Given IV
Overall Study STARTED	7	8	3
Overall Study COMPLETED	7	8	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab With Rituximab or Obinutuzumab in Treating Patients With Relapsed or Refractory Follicular Lymphoma or Diffuse Large B Cell Lymphoma

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 90 days after the last dose of pembrolizumab

Will be defined as the rate of complete + partial responses using computed tomography (CT) criteria (Lugano 2014).

Outcome measures

Outcome measures
Measure	Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) n=7 Participants INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm II DLBCL (Pembrolizumab, Rituximab) n=8 Participants INDUCTION: Patients with R/R DLBCL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) n=3 Participants INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Obinutuzumab: Given IV
Overall Response Rate	29 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 90 days after the last dose of pembrolizumab

Evaluated by the NCI Common Terminology for Adverse Events (CTCAE), version 4.0.

Outcome measures

Outcome measures
Measure	Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) n=7 Participants INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm II DLBCL (Pembrolizumab, Rituximab) n=8 Participants INDUCTION: Patients with R/R DLBCL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) n=3 Participants INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Obinutuzumab: Given IV
Incidence of Serious or Drug-related Adverse Events	100 percentage of participants	63 percentage of participants	67 percentage of participants

SECONDARY outcome

Timeframe: Up to 90 days after the last dose of pembrolizumab

The Kaplan-Meier method will be used to estimate median PFS.

Outcome measures

Outcome measures
Measure	Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) n=7 Participants INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm II DLBCL (Pembrolizumab, Rituximab) n=8 Participants INDUCTION: Patients with R/R DLBCL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) n=3 Participants INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Obinutuzumab: Given IV
Progression-free Survival (PFS)	0.23 years Interval 0.18 to Upper bound could not be calculated due to insufficient number of participants with events.	0.21 years Interval 0.11 to Upper bound could not be calculated due to insufficient number of participants with events..	0.50 years Interval 0.38 to Upper bound could not be calculated due to insufficient number of participants with events..

SECONDARY outcome

Timeframe: Up to 90 days after the last dose of pembrolizumab

The Kaplan-Meier method will be used to estimate median OS.

Outcome measures

Outcome measures
Measure	Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) n=7 Participants INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm II DLBCL (Pembrolizumab, Rituximab) n=8 Participants INDUCTION: Patients with R/R DLBCL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) n=3 Participants INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Obinutuzumab: Given IV
Overall Survival (OS)	NA years Interval 3.1 to Median and upper bound could not be calculated due to insufficient number of participants with events..	1.5 years Interval 0.65 to Upper bound could not be calculated due to insufficient number of participants with events..	NA years Interval 1.1 to Median and upper bound could not be calculated due to insufficient number of participants with events..

Adverse Events

Arm I Follicular Lymphoma (Pembrolizumab, Rituximab)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 2 deaths

Arm II DLBCL (Pembrolizumab, Rituximab)

Serious events: 5 serious events

Other events: 8 other events

Deaths: 5 deaths

Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) n=7 participants at risk INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm II DLBCL (Pembrolizumab, Rituximab) n=8 participants at risk INDUCTION: Patients with R/R DLBCL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) n=3 participants at risk INDUCTION: Patients with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Obinutuzumab: Given IV
Gastrointestinal disorders Diarrhea	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Psychiatric disorders Altered mental status	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
General disorders Fever	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Infections and infestations Streptococcus salivarius	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Cardiac disorders Heart Failure	14.3% 1/7 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/8 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Investigations Hypercalcemia	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Cardiac disorders Pericarditis	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/7 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	14.3% 1/7 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/8 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Infections and infestations Pneumonia	14.3% 1/7 • Number of events 1 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/8 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	0.00% 0/3 • Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Other adverse events

Additional Information

Stephen Smith, MD

University of Washington

Phone: (206) 606-6546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) n=7 Participants INDUCTION: Patients Diagnosed with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm II DLBCL (Pembrolizumab, Obinutuzumab) n=8 Participants INDUCTION: Patients diagnosed with R/R DLBCL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Rituximab: Given IV	Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) n=3 Participants INDUCTION: Patients diagnosed with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Obinutuzumab: Given IV	Total n=18 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	3 participants n=5 Participants	18 participants n=4 Participants