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Monoclonal Antibodies

Immunotherapy for Lymphoma

Phase 2

Waitlist Available

Led By Stephen D. Smith

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For DLBCL, patients must have relapsed after, declined, or considered ineligible for high-dose chemotherapy and autologous stem cell transplantation

Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale

Must not have

Has known history of, or any evidence of active, non-infectious pneumonitis/interstitial lung disease

Has an active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days after the last dose of pembrolizumab

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two immunotherapy drugs to treat patients with either follicular lymphoma or diffuse large B cell lymphoma that has returned or doesn't respond to treatment. The immunotherapy drugs are pembrolizumab and either rituximab or obinutuzumab. Rituximab and obinutuzumab are monoclonal antibodies that bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The drugs may help kill more cancer cells.

Who is the study for?

This trial is for adults with relapsed or refractory follicular lymphoma or diffuse large B cell lymphoma. They must have tried certain treatments like CD20 antibody therapy, not be eligible for high-dose chemotherapy and stem cell transplant, and lack better treatment options. Participants need a minimum hemoglobin level, measurable disease, good performance status (able to carry out daily activities), adequate organ function, and agree to use contraception.

What is being tested?

The study tests pembrolizumab combined with either rituximab or obinutuzumab in patients whose lymphoma has returned after treatment or hasn't responded to previous therapies. Pembrolizumab is an immunotherapy drug that may help the immune system attack cancer cells; rituximab and obinutuzumab are antibodies targeting specific proteins on cancer cells.

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, fever, chills, body aches similar to flu symptoms from rituximab or obinutuzumab. Pembrolizumab can cause immune-related adverse effects such as inflammation of organs like lungs (pneumonitis) or intestines (colitis), skin rash, liver enzyme elevation indicating liver inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My DLBCL has returned or I can't have high-dose chemo and stem cell transplant.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function is within the required range for the study.

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My blood clotting time is normal or managed if I'm on blood thinners.

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My lymphoma has returned or didn't respond to treatment.

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My cancer can be measured and is at least 1.5 cm big.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had lung inflammation not caused by an infection.

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I am currently being treated for an infection.

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I have been diagnosed with HIV.

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I am not on steroids or immunosuppressants, except for necessary hormone replacement.

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I have an active tuberculosis infection.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.

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I've had cancer treatment within the last 2 weeks or still have side effects.

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I have active brain metastases or cancer in the lining of my brain.

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I have an autoimmune disease treated with medication in the last 2 years.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I had a transplant from another person within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days after the last dose of pembrolizumab

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days after the last dose of pembrolizumab

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days after the last dose of pembrolizumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate

Secondary study objectives

Incidence of serious or drug-related adverse events

Overall survival (OS)

Progression-free survival (PFS)

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (pembrolizumab, obinutuzumab)Experimental Treatment3 Interventions

INDUCTION: Patients 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.

Group II: Arm I (pembrolizumab, rituximab)Experimental Treatment3 Interventions

INDUCTION: Patients 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Obinutuzumab

2014

Completed Phase 3

~3470