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Nivolumab Maintenance for Diffuse Large B-Cell Lymphoma

Phase < 1
Waitlist Available
Led By Shazia Nakhoda, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Autologous transplant must have been done 100 days prior to the study enrollment
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is for patients with DLBCL who have relapsed within 12 months of chemotherapy. The purpose of the trial is to use circulating tumor DNA (ctDNA) to detect relapse at an early stage, and to treat with Nivolumab to prevent complete relapse.

Who is the study for?
This trial is for adults over 18 with diffuse large B-cell lymphoma who've had successful chemo and are in remission. They must have a life expectancy of at least 3 months, be willing to use contraception, and not have used certain immune therapies or had an allogeneic transplant. People with other cancers or serious health issues like heart disease, uncontrolled infections, or severe psychiatric conditions can't join.Check my eligibility
What is being tested?
The study tests if monitoring patients using circulating tumor DNA (ctDNA) can catch cancer relapse early. Those with ctDNA after chemo will receive Nivolumab every two weeks for up to two years to prevent full relapse.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs, skin rash, hormone gland problems (like thyroid), lung issues (pneumonitis), intestinal problems (colitis), liver inflammation (hepatitis), kidney inflammation (nephritis), and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stem cell transplant using my own cells more than 100 days ago.
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I am older than 18 years.
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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 can provide a tissue sample of my tumor for analysis.
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My blood counts and liver/kidney functions are within safe ranges.
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I finished my radiation therapy at least 2 weeks ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of the rate of conversion from positive to negative ctDNA in nivolumab treated patients
Secondary outcome measures
Proportion of patients who are able to convert from ctDNA positive to ctDNA negative after nivolumab treatment
Adult Fanconi syndrome
To compare the ctDNA results of Clonoseq and Neolabs platform
+1 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: NivolumabExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,494 Total Patients Enrolled
Shazia Nakhoda, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Nivolumab, IV, 240 mg Clinical Trial Eligibility Overview. Trial Name: NCT03311958 — Phase < 1
Non-Hodgkin's Lymphoma Research Study Groups: Nivolumab
Non-Hodgkin's Lymphoma Clinical Trial 2023: Nivolumab, IV, 240 mg Highlights & Side Effects. Trial Name: NCT03311958 — Phase < 1
Nivolumab, IV, 240 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT03311958 — 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 threshold of people who can join this research endeavor?

"This study is no longer recruiting due to it's initial posting on May 15th 2018 and last update on August 8th 2022. However, there are 1782 trials targeting individuals with diffuse large b-cell lymphoma (dlbcl) and 717 studies related to Nivolumab IV 240 mg that remain actively seeking participants."

Answered by AI

To what medical condition is Nivolumab, IV, 240 mg typically administered?

"Nivolumab, IV at a dosage of 240 mg is an effective treatment for malignant neoplasms such as unresectable melanoma and squamous cell carcinoma."

Answered by AI

Has Nivolumab, IV, 240 mg been used in any previous clinical experiments?

"Currently, 717 live medical studies are assessing the efficacy of Nivolumab IV 240 mg with 83 trials in Phase 3. While some research sites for this drug are located in Basel, BE, 41196 locations around the world have opened trials to examine its effects."

Answered by AI

Is this trial an inaugural effort towards a particular medical advancement?

"The pharmaceutical company Ono Pharmaceutical Co. Ltd kickstarted the research for Nivolumab, IV, 240 mg in 2012 with a clinical trial involving 659 patients. Following its successful completion and Phase 1 & 2 drug approval it has since been studied in 717 active trials across 2362 cities and 49 countries worldwide."

Answered by AI

Is this research initiative currently recruiting participants?

"The information on clinicialtrials.gov confirms that this particular trial is not recruiting any participants at present, despite having posted and updated the study since its initial posting of May 15th 2018. Nevertheless, there are 2499 other medical studies actively enlisting volunteers right now."

Answered by AI
~0 spots leftby May 2024