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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment up to two years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a male and agree to follow the contraception guidelines for 5 months after my last treatment.
Select...
I have a tumor larger than 1 cm that can be felt or seen with ultrasound.
Select...
I am 18 or older with a confirmed diagnosis of relapsed or refractory Hodgkin or Non-Hodgkin Lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment up to two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT0361864182%
Investigations - Other, specify
65%
Chills
65%
Hyponatremia
56%
Fever
53%
Fatigue
38%
Anemia
35%
Hypertension
35%
Nausea
29%
Diarrhea
29%
Musculoskeletal and connective tissue disorder - Other, specify
29%
Hypophosphatemia
26%
General disorders and administration site conditions - Other, specify
26%
Injection site reaction
26%
Hypoalbuminemia
26%
Skin and subcutaneous tissue disorders - Other, specify
24%
Platelet count decreased
24%
Headache
24%
Neutrophil count decreased
21%
Arthralgia
21%
Pain
21%
Vomiting
21%
Hyperuricemia
21%
Hypokalemia
21%
Hypermagnesemia
21%
Proteinuria
21%
Hematuria
18%
Back pain
18%
Infections and infestations - Other, specify
18%
White blood cell decreased
18%
Hyperglycemia
18%
Hypocalcemia
18%
Sinus tachycardia
15%
Pain in extremity
15%
Insomnia
15%
Sinus bradycardia
15%
Lymphocyte count decreased
15%
Anorexia
15%
Hypomagnesemia
15%
Pruritus
15%
Edema limbs
12%
Metabolism and nutrition disorders - Other, specify
12%
Cytokine release syndrome
12%
Alanine aminotransferase increased
12%
Aspartate aminotransferase increased
12%
Rash maculo-papular
9%
Nervous system disorders - Other, specify
9%
Constipation
9%
Mucositis oral
9%
Infusion related reaction
9%
Alkaline phosphatase increased
9%
Hypotension
9%
Dyspnea
9%
Cough
9%
Hyperkalemia
9%
Renal and urinary disorders - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
9%
Creatinine increased
9%
Anxiety
6%
Sore throat
6%
Flushing
6%
Weight gain
6%
Blurred vision
6%
Eye disorders - Other, specify
6%
Neck pain
6%
Postnasal drip
6%
Dizziness
6%
Flu like symptoms
6%
Seroma
6%
Weight loss
6%
Hypoglycemia
6%
Upper respiratory infection
6%
Wound infection
6%
Injury, poisoning and procedural complications - Other, specify
6%
Activated partial thromboplastin time prolonged
6%
Blood bilirubin increased
3%
Muscle weakness upper limb
3%
INR increased
3%
Arthritis
3%
Endocrine disorders - Other, specify
3%
Dry mouth
3%
Myositis
3%
Generalized muscle weakness
3%
Myalgia
3%
Dysgeusia
3%
Movements involuntary
3%
Paresthesia
3%
Immune system disorders - Other, specify
3%
Restrictive cardiomyopathy
3%
Depression
3%
Nasal congestion
3%
Floaters
3%
Pneumonitis
3%
Soft tissue infection
3%
Adrenal insufficiency
3%
Thromboembolic event
3%
Hypothyroidism
3%
Dyspepsia
3%
Oral pain
3%
Malaise
3%
Neck edema
3%
Joint infection
3%
Sinusitis
3%
Radiation recall reaction (dermatologic)
3%
Cardiac troponin I increased
3%
Hypernatremia
3%
Respiratory, thoracic and mediastinal disorders - Other, specify
3%
Rash acneiform
3%
Skin hypopigmentation
3%
Hematoma
3%
Lymphedema
3%
Atelectasis
3%
Erythema multiforme
3%
Photosensitivity
3%
Hypoxia
3%
Flashing lights
3%
Edema face
3%
Colonic obstruction
3%
Gastritis
3%
Hemorrhoids
3%
Vaginal infection
3%
Fall
3%
Urinary tract pain
3%
Urine discoloration
3%
Cardiac disorders - Other, specify
3%
Alopecia
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
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
~380
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,884 Previous Clinical Trials
5,054,346 Total Patients Enrolled
91 Trials studying Lymphoma
8,726 Patients Enrolled for Lymphoma
University of IowaOTHER
446 Previous Clinical Trials
879,463 Total Patients Enrolled
3 Trials studying Lymphoma
20,103 Patients Enrolled for Lymphoma
Umar FarooqLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine within the last 30 days.My cancer can be measured and has grown in previously treated areas.My organ function is not within the required range for the study.I have not had active treatment for another cancer, except for certain skin cancers or localized cancers, in the last 3 years.I have given my written consent to participate and can follow the study's requirements.You have taken part in a study for an experimental drug or used an experimental medical device within the past month or 5 half-lives, whichever is shorter.I have been treated with specific immune therapy drugs within the last 4 weeks.I have a primary immune disorder or have been on high-dose steroids or immunosuppressants recently.My brain metastases are stable, and I haven't needed steroids for 14 days.I am currently being treated for an infection.I have had B cell therapy but my B cell count is sufficient or I've responded well to a test vaccine.If you are a woman who is able to have children, you agree to use birth control during the study and for at least 5 months after the study ends.I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation from it.My kidney function, measured by creatinine or GFR, is within the required range.I am a male and agree to follow the contraception guidelines for 5 months after my last treatment.I am a woman not pregnant or breastfeeding and meet one of the specific conditions.I have fully recovered from any major surgery before starting the study treatment.I have not had an organ transplant or GVHD in the last 5 years.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?My blood clotting levels are normal or managed if I'm on blood thinners.I haven't had a blood transfusion or needed erythropoietin in the last 2 weeks.I have a tumor larger than 1 cm that can be felt or seen with ultrasound.I am 18 or older with a confirmed diagnosis of relapsed or refractory Hodgkin or Non-Hodgkin Lymphoma.I have recovered from side effects of previous treatments, except for mild neuropathy.I haven't taken any cancer treatment or experimental drugs within the last 2 weeks.My liver function tests are within the required range.I have a history of Hepatitis B or active Hepatitis C.I have or had lung inflammation that needed steroids.You have mental health or drug/alcohol addiction issues that may make it hard for you to follow the trial requirements.I am fully active or restricted in physically strenuous activity but can do light work.I have an autoimmune disease treated with strong medication in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: CMP-001 plus pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the main indications for CMP-001?
"CMP-001 is a medication used to treat malignant neoplasms, but it can also be helpful for patients experiencing disease progression after chemotherapy or those with unresectable melanoma."
Answered by AI
Is this research the first of its kind to test CMP-001?
"CMP-001 is being trialled in 1000 active studies, with the majority of these being Phase 3 trials. The central location for these investigations is Houston, Texas; however, CMP-001 clinical trials are happening in 36030 locations worldwide."
Answered by AI
How many individuals are being given this treatment as part of the research?
"That is correct. The online information from clinicaltrials.gov reveals that this study, which was originally advertised on 1/31/2020, has active recruitment. 39 subjects are needed to complete the trial at a single location."
Answered by AI
Are patients being accepted into this trial at this time?
"That is correct, the information available on clinicaltrials.gov does show that this study is still recruiting patients. This particular trial was first posted on 1/31/2020, and the most recent update was on 4/21/2022. 39 participants are needed for enrollment at 1 location."
Answered by AI
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