Trial Outcomes & Findings for Pembrolizumab and External Beam Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NCT NCT03210662)

Last Updated: 2026-01-13

Results Overview

Disease response will be assessed via revised Lugano classification for the response assessment of Hodgkin and non-Hodgkin lymphoma. The end of treatment assessment is determined by positron emission tomography (PET)-computed tomography (CT) imaging for patients with fluoro-deoxyglucose (FDG) avid hematologic malignancies. For patients with FDG-avid disease, the Deauville Criteria will be utilized for PET-CT scoring on a 5 point 5-point scale, in accordance with standard response criteria. A score of 1-3 is considered negative a score of 4-5 is considered positive for the presence of active lymphoma.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Every 3 months until withdrawal of consent, becoming lost to follow-up, or death (an average of 14 months).

Results posted on

2026-01-13

Participant Flow

Recruited from MD Anderson clinics from February 2018 until October 2021

Participant milestones

Participant milestones
Measure	Total MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Overall Study STARTED	17
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab and External Beam Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=17 Participants MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Age, Categorical <=18 years	0 Participants n=210 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=210 Participants
Age, Categorical >=65 years	9 Participants n=210 Participants
Age, Continuous	59.9 years n=210 Participants
Sex: Female, Male Female	5 Participants n=210 Participants
Sex: Female, Male Male	12 Participants n=210 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=210 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=210 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=210 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants
Race (NIH/OMB) Asian	2 Participants n=210 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=210 Participants
Race (NIH/OMB) Black or African American	1 Participants n=210 Participants
Race (NIH/OMB) White	13 Participants n=210 Participants
Race (NIH/OMB) More than one race	0 Participants n=210 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=210 Participants
Region of Enrollment United States	17 participants n=210 Participants

PRIMARY outcome

Timeframe: Every 3 months until withdrawal of consent, becoming lost to follow-up, or death (an average of 14 months).

Outcome measures

Outcome measures
Measure	Total n=17 Participants MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)	Non-irradiated Lesion MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Overall Response Rate of Pembrolizumab With Concurrent Fractionated External Beam Radiotherapy (EBRT) Among Patients With Relapsed and Refractory Non-Hodgkin Lymphoma (NHL)	5 Participants	—

SECONDARY outcome

Timeframe: 1.8 ~ 6.5 months

Outcome measures

Outcome measures
Measure	Total n=17 Participants MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)	Non-irradiated Lesion MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Progression Free Survival	2.7 Months Interval 1.8 to 6.5	—

SECONDARY outcome

Timeframe: Every 3 months until withdrawal of consent, becoming lost to follow-up, or death.

The measurement of overall survival of patients from the start of trial participation until the death of the patient.

Outcome measures

Outcome measures
Measure	Total n=17 Participants MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)	Non-irradiated Lesion MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Overall Survival	6.2 Months Interval 4.5 to Insufficient number of participants with events	—

SECONDARY outcome

Timeframe: Every 3 months until withdrawal of consent, becoming lost to follow-up, or death (an average of 14 months).

Outcome measures

Outcome measures
Measure	Total n=16 Participants MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)	Non-irradiated Lesion n=16 Participants MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Overall and Complete Response Rate of Irradiated vs Non-Irradiated Lesions PR/CR control of lesions	10 participants	3 participants
Overall and Complete Response Rate of Irradiated vs Non-Irradiated Lesions No PR/CR control of lesions	6 participants	13 participants

SECONDARY outcome

Timeframe: Through Study Completion (an average of 14 months)

Population: Number of Patients removed from study for Toxicity/Safety reasons

Assessing patients who discontinued study treatment due to toxicity/safety concerns

Outcome measures

Outcome measures
Measure	Total n=17 Participants MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)	Non-irradiated Lesion MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Safety of Pembrolizumab With Fractionated EBRT Participants off treatment for toxicity/safety reasons	1 participants	—
Safety of Pembrolizumab With Fractionated EBRT Participants off treatment for non-safety reasons	16 participants	—

Adverse Events

Total

Serious events: 10 serious events

Other events: 16 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Total n=17 participants at risk MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Infections and infestations Lung Infection	11.8% 2/17 • Number of events 5 • Through study completion (an average of 14 months)
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • Number of events 2 • Through study completion (an average of 14 months)
Blood and lymphatic system disorders Platelet Count Decreased	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
Investigations Hypoxia	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
General disorders Delirium	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Musculoskeletal and connective tissue disorders Flank pain	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Infections and infestations Tumor pain	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Blood and lymphatic system disorders Lymph node pain	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Vascular disorders Thromboembolic event	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Musculoskeletal and connective tissue disorders Fracture	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
General disorders Pain	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Blood and lymphatic system disorders Hypercalcemia	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Gastrointestinal disorders Mucositis oral	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)

Other adverse events

Other adverse events
Measure	Total n=17 participants at risk MK-3475 at 200 mg every 21 days for 35 cycles with concurrent EBRT (unirradiated lesions)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Respiratory, thoracic and mediastinal disorders Atelectasis	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Investigations Alanine Aminotransferase Increased	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Investigations Alkaline Phosphatase Increased	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
Investigations Aspartate Aminotransferase Increased	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Investigations Lymphocyte count decreased	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
Investigations White blood cell decreased	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Nervous system disorders Dysgeusia	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Investigations Neutrophil count decreased	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Cardiac disorders Palpitations	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Gastrointestinal disorders Mucositis Oral	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Investigations Hypoxia	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
Respiratory, thoracic and mediastinal disorders Productive cough	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
General disorders Fever	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
General disorders Chills	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Investigations Weight loss	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
General disorders Malaise	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Nervous system disorders Paresthesia	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Blood and lymphatic system disorders Anemia	23.5% 4/17 • Number of events 5 • Through study completion (an average of 14 months)
General disorders Fatigue	64.7% 11/17 • Number of events 12 • Through study completion (an average of 14 months)
General disorders Pain	17.6% 3/17 • Number of events 3 • Through study completion (an average of 14 months)
Skin and subcutaneous tissue disorders Erythema Multiforme	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Investigations Platelet Count Decreased	11.8% 2/17 • Number of events 3 • Through study completion (an average of 14 months)
Skin and subcutaneous tissue disorders Prutirus	23.5% 4/17 • Number of events 4 • Through study completion (an average of 14 months)
Skin and subcutaneous tissue disorders Rash maculopapular	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Metabolism and nutrition disorders Hypothyroidism	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Gastrointestinal disorders Diarrhea	17.6% 3/17 • Number of events 3 • Through study completion (an average of 14 months)
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Respiratory, thoracic and mediastinal disorders Dyspnea	17.6% 3/17 • Number of events 6 • Through study completion (an average of 14 months)
Gastrointestinal disorders Nausea	17.6% 3/17 • Number of events 4 • Through study completion (an average of 14 months)
Infections and infestations Lung infection	17.6% 3/17 • Number of events 4 • Through study completion (an average of 14 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.9% 1/17 • Number of events 1 • Through study completion (an average of 14 months)
Metabolism and nutrition disorders Anorexia	11.8% 2/17 • Number of events 2 • Through study completion (an average of 14 months)
Skin and subcutaneous tissue disorders Radiation Dermatitis	29.4% 5/17 • Number of events 6 • Through study completion (an average of 14 months)

Additional Information

Chelsea C. Pinnix, MD

M.D. Anderson Cancer Center

Phone: 713-563-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place