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Immunomodulatory Agent

Pomalidomide + Nivolumab for Viral Associated Cancers

Phase 1
Recruiting
Led By Kathryn A Lurain, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
Current or history of systemic autoimmune disease requiring systemic immunosuppressive therapy will not be allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months of treatment, until confirmed progression, unacceptable toxicity or trial withdrawal
Awards & highlights

Study Summary

This trial is testing a combination of two drugs to treat cancers caused by viruses. The drugs are pomalidomide and nivolumab, and the trial will test to see if they are safe and effective in treating these cancers.

Who is the study for?
Adults 18+ with virus-related cancers (like Kaposi sarcoma, lymphoma) that are advanced, not curable by surgery or have come back after treatment. This includes people with HIV and any CD4 count. Must be able to take daily aspirin, have good organ function, and use birth control if needed. Can't join if on strong immune system drugs, severe health issues, pregnant/nursing, had certain treatments recently or allergic to the trial drugs.Check my eligibility
What is being tested?
The trial is testing a combo of two drugs: Pomalidomide taken orally for 21 days in a cycle and Nivolumab given via IV once each cycle for up to 24 cycles. The goal is to find a safe dose for people whose cancer is caused by viruses like EBV or HPV.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from the IV drug administration, fatigue, blood clots requiring aspirin use throughout the study period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I do not have an autoimmune disease that needs strong immune system-suppressing drugs.
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My blood cancer can be measured or tracked.
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I have had immunotherapy before and did not experience severe side effects.
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My cancer is caused by a virus, cannot be cured by surgery or other treatments, and has not responded to first treatments.
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I can take aspirin 81mg daily or a similar blood thinner.
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My tumor type is eligible and has been tested for specific viral infections.
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I have another cancer type, but it won't affect this trial's treatment.
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My organs and bone marrow work well.
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My brain cancer has not worsened after treatment.
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I am 18 years old or older.
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My heart and lungs are healthy enough for treatment.
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My solid tumor can be measured by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months of treatment, until confirmed progression, unacceptable toxicity or trial withdrawal
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months of treatment, until confirmed progression, unacceptable toxicity or trial withdrawal for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of pomalidomide with nivolumab
Secondary outcome measures
anti-tumor activity and clinical benefits

Side effects data

From 2015 Phase 2 trial • 36 Patients • NCT02011113
72%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
PYREXIA
25%
CONSTIPATION
25%
NASOPHARYNGITIS
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
DYSGEUSIA
14%
PNEUMONIA
11%
FATIGUE
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
11%
EPISTAXIS
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
RASH MACULO-PAPULAR
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
WEIGHT INCREASED
6%
CANCER PAIN
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
DECUBITUS ULCER
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
PERIPHERAL SENSORY NEUROPATHY
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
CYSTITIS
6%
GASTROENTERITIS
6%
DIABETES MELLITUS
6%
RESTLESSNESS
6%
INCREASED APPETITE
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
SEPSIS
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
MULTI-ORGAN FAILURE
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
3%
PNEUMONIA PNEUMOCOCCAL
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Dose ExpansionExperimental Treatment2 Interventions
Nivolumab + pomalidomide (at optimal dose determined in dose escalation portion of the study) for up to 30 participants
Group II: 1/Dose De-EscalationExperimental Treatment2 Interventions
Treatment with pomalidomide at de-escalating doses if necessary and nivolumab at a fixed dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,293 Total Patients Enrolled
Kathryn A Lurain, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Nivolumab (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04902443 — Phase 1
Viral Associated Cancers Research Study Groups: 1/Dose De-Escalation, 2/Dose Expansion
Viral Associated Cancers Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04902443 — Phase 1
Nivolumab (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04902443 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of enrolment for this clinical trial?

"Affirmative. The trial information hosted on clinicaltrials.gov affirms that this medical study, first introduced on December 10th 2021 is actively recruiting. 54 participants are required from a single site."

Answered by AI

Has the Federal Drug Administration greenlighted Pomalidomide?

"The safety of Pomalidomide is graded at 1, as there exists limited data to support its efficacy and only preliminary studies have been conducted to understand its potential risks."

Answered by AI

Is recruitment for this experiment still ongoing?

"Affirmative. Per the records on clinicaltrials.gov, enrollment for this medical trial is currently open. The experiment was first published online on December 10th 2021 and its most recent amendment took place on October 4th 2022. A total of 54 participants need to be recruited from 1 site in order to complete the study's aims."

Answered by AI

Has Pomalidomide been previously explored in medical trials?

"Presently, there are 802 clinical trials that investigate the efficacy of Pomalidomide with 92 studies in its third phase. While Zürich, BE hosts many of these investigations, 43 042 sites worldwide have active research for this medication."

Answered by AI

What indications is Pomalidomide traditionally employed to treat?

"Pomalidomide can be used to treat a variety of malignant tumours, including melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI
~23 spots leftby Dec 2025