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Virus Therapy

CMP-001 + Pembrolizumab for Lymphoma

Phase 1 & 2
Waitlist Available
Led By Umar Farooq, MD
Research Sponsored by Umar Farooq
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants: A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least five months after the final CMP-001 and pembrolizumab dose and refrain from donating sperm during this period.
Subjects must have at least one tumor lesion with a longest diameter of ≥ 1 cm that can be easily palpated or detected by ultrasound to facilitate intratumoral injection of CMP-001 (eg, tumor in skin, muscle, subcutaneous tissue or accessible lymph node).
Must not have
Has an active infection requiring systemic therapy.
Has a diagnosis of primary immunodeficiency disorder or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment up to two years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to see if it's effective and has acceptable side effects for people with lymphoma who haven't responded to other treatments.

Who is the study for?
Adults with relapsed or refractory Hodgkin or Non-Hodgkin Lymphoma who've had prior B cell therapy are eligible. They must have measurable disease, be in good physical condition (ECOG 0-1), and agree to use contraception. Exclusions include lung disease requiring steroids, certain psychiatric/substance abuse disorders, recent other cancer treatments, live vaccines within a month, active infections like Hepatitis/HIV, autoimmune diseases treated within two years.
What is being tested?
The trial is testing CMP-001 combined with pembrolizumab for lymphoma patients who haven't responded well to previous treatments. It's an early phase trial aiming to find the right dose that works best while keeping side effects manageable.
What are the potential side effects?
Possible side effects may include reactions at the injection site of CMP-001 and immune-related adverse effects from pembrolizumab such as fatigue, skin issues, inflammation in organs like lungs or intestines, hormonal imbalances and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male and agree to follow the contraception guidelines for 5 months after my last treatment.
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I have a tumor larger than 1 cm that can be felt or seen with ultrasound.
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I am 18 or older with a confirmed diagnosis of relapsed or refractory Hodgkin or Non-Hodgkin Lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for an infection.
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I have a primary immune disorder or have been on high-dose steroids or immunosuppressants recently.
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My kidney function, measured by creatinine or GFR, is within the required range.
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I have not had an organ transplant or GVHD in the last 5 years.
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I'm sorry, it seems like you forgot to provide the criterion for me to rewrite. Could you please provide it so I can assist you?
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I haven't taken any cancer treatment or experimental drugs within the last 2 weeks.
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My liver function tests are within the required range.
Select...
I have or had lung inflammation that needed steroids.
Select...
I have an autoimmune disease treated with strong medication in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment up to two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment up to two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicities using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Objective response rate with statistical analysis based on the EffTox method

Side effects data

From 2023 Phase 2 trial • 34 Patients • NCT03618641
82%
Investigations - Other, specify
65%
Chills
65%
Hyponatremia
56%
Fever
53%
Fatigue
38%
Anemia
35%
Nausea
35%
Hypertension
29%
Diarrhea
29%
Hypophosphatemia
29%
Musculoskeletal and connective tissue disorder - Other, specify
26%
General disorders and administration site conditions - Other, specify
26%
Injection site reaction
26%
Hypoalbuminemia
26%
Skin and subcutaneous tissue disorders - Other, specify
24%
Neutrophil count decreased
24%
Platelet count decreased
24%
Headache
21%
Vomiting
21%
Pain
21%
Hypermagnesemia
21%
Hyperuricemia
21%
Hypokalemia
21%
Arthralgia
21%
Hematuria
21%
Proteinuria
18%
Sinus tachycardia
18%
Infections and infestations - Other, specify
18%
White blood cell decreased
18%
Hyperglycemia
18%
Hypocalcemia
18%
Back pain
15%
Sinus bradycardia
15%
Edema limbs
15%
Lymphocyte count decreased
15%
Anorexia
15%
Hypomagnesemia
15%
Pain in extremity
15%
Insomnia
15%
Pruritus
12%
Cytokine release syndrome
12%
Alanine aminotransferase increased
12%
Aspartate aminotransferase increased
12%
Metabolism and nutrition disorders - Other, specify
12%
Rash maculo-papular
9%
Blood and lymphatic system disorders - Other, specify
9%
Constipation
9%
Mucositis oral
9%
Infusion related reaction
9%
Alkaline phosphatase increased
9%
Creatinine increased
9%
Hyperkalemia
9%
Nervous system disorders - Other, specify
9%
Renal and urinary disorders - Other, specify
9%
Cough
9%
Dyspnea
9%
Hypotension
9%
Anxiety
6%
Blurred vision
6%
Eye disorders - Other, specify
6%
Flu like symptoms
6%
Upper respiratory infection
6%
Wound infection
6%
Injury, poisoning and procedural complications - Other, specify
6%
Seroma
6%
Weight gain
6%
Weight loss
6%
Hypoglycemia
6%
Neck pain
6%
Dizziness
6%
Postnasal drip
6%
Sore throat
6%
Flushing
6%
Activated partial thromboplastin time prolonged
6%
Blood bilirubin increased
3%
Restrictive cardiomyopathy
3%
Immune system disorders - Other, specify
3%
Soft tissue infection
3%
Thromboembolic event
3%
Cardiac disorders - Other, specify
3%
Adrenal insufficiency
3%
Endocrine disorders - Other, specify
3%
Hypothyroidism
3%
Flashing lights
3%
Floaters
3%
Colonic obstruction
3%
Dry mouth
3%
Dyspepsia
3%
Gastritis
3%
Hemorrhoids
3%
Oral pain
3%
Edema face
3%
Malaise
3%
Neck edema
3%
Joint infection
3%
Sinusitis
3%
Vaginal infection
3%
Fall
3%
Radiation recall reaction (dermatologic)
3%
Cardiac troponin I increased
3%
INR increased
3%
Hypernatremia
3%
Arthritis
3%
Generalized muscle weakness
3%
Muscle weakness upper limb
3%
Myalgia
3%
Myositis
3%
Dysgeusia
3%
Movements involuntary
3%
Paresthesia
3%
Depression
3%
Urinary tract pain
3%
Urine discoloration
3%
Atelectasis
3%
Hypoxia
3%
Nasal congestion
3%
Pneumonitis
3%
Respiratory, thoracic and mediastinal disorders - Other, specify
3%
Alopecia
3%
Erythema multiforme
3%
Photosensitivity
3%
Rash acneiform
3%
Skin hypopigmentation
3%
Hematoma
3%
Lymphedema
3%
Peripheral motor neuropathy
3%
Peripheral sensory neuropathy
3%
Syncope
3%
Tremor
3%
Confusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nivolumab and CMP-001 Combination

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CMP-001 plus pembrolizumabExperimental Treatment2 Interventions
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CMP-001
2018
Completed Phase 2
~320
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,019 Previous Clinical Trials
5,186,468 Total Patients Enrolled
97 Trials studying Lymphoma
8,969 Patients Enrolled for Lymphoma
University of IowaOTHER
468 Previous Clinical Trials
893,452 Total Patients Enrolled
3 Trials studying Lymphoma
20,103 Patients Enrolled for Lymphoma
Umar FarooqLead Sponsor

Media Library

CMP-001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03983668 — Phase 1 & 2
Lymphoma Research Study Groups: CMP-001 plus pembrolizumab
Lymphoma Clinical Trial 2023: CMP-001 Highlights & Side Effects. Trial Name: NCT03983668 — Phase 1 & 2
CMP-001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03983668 — Phase 1 & 2
~7 spots leftby Dec 2025
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