← Back to Search

Agonist

Nivolumab for Skin Cancer

Q: How many test subjects are currently engaged in this experiment?

Regrettably, this clinical trial is currently not recruiting. It was first advertised on March 8th 2016 and last updated on September 27th 2022. However, there are plenty of other studies available; 825 focusing on <a href="https://www.withpower.com/clinical-trials/skin-cancer">skin cancer</a> and 1604 trials involving Nivolumab have open enrollment at the time of writing.

Q: What other investigations have been done using Nivolumab?

Currently, there are 1604 clinical trials underway that research Nivolumab of which 243 are in the final Phase 3. While most trials take place in Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>, a total of 68053 sites around the world are running studies on it.

Q: What conditions benefit most from the prescription of Nivolumab?

Nivolumab can be deployed to treat a variety of ailments, including but not limited to: <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, acute and malignant neoplasms, myelocytic disorders, as well as <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>.

Q: Is this research initiative still accepting participants?

Unfortunately, this clinical trial is not accepting participants at the moment. According to its posting date of March 8th 2016 and latest update on September 27th 2022, it appears that recruitment has ceased. If you are in search for other studies related to <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> of the skin or Nivolumab there are presently 825 and 1604 trials respectively actively recruiting patients.

Phase < 1

Waitlist Available

Led By Amod Sarnaik, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 27 months

Awards & highlights

Study Summary

This trial will study the safety and feasibility of using tumor-infiltrating lymphocytes (TILs) with the drug nivolumab to treat cancer. Nivolumab is an immunotherapy drug that helps the immune system fight cancer, infection, and other diseases.

Eligible Conditions

Skin Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Study Related Adverse Events

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%

Pyrexia

21%

Neutropenia

19%

Hypomagnesaemia

19%

Headache

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Rash

14%

Hyponatraemia

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Muscular weakness

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Upper respiratory tract infection

Abdominal pain upper

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Hyperkalaemia

Dehydration

Hyperglycaemia

Chills

Blood alkaline phosphatase increased

Hypertension

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Femur fracture

Bone pain

Pericardial effusion malignant

Confusional state

Pneumothorax

Neoplasm progression

Circulatory collapse

Atrial flutter

Bronchial obstruction

Hypercalcaemia

Superior vena cava syndrome

Cancer pain

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: PD-1, CD137 and Adoptive Cell TherapyExperimental Treatment7 Interventions

Combination Therapy and Immunotherapy as described in intervention descriptions. Nivolumab Treatment: The first 6 participants will not have pre-treatment with nivolumab and instead will be scheduled for the removal of their tumor sample for tumor Infiltrating lymphocytes (TIL) growth in the lab. The second 6 participants will receive treatment with nivolumab prior to removal of tumor sample for TIL growth; about 2 weeks after their tumor sample has been taken, these participants may receive additional infusions of nivolumab. Surgery to remove tumor for growth of TIL followed by: TIL growth process; lymphodepleting chemotherapy with cyclophosphamide and fludarabine; TIL infusion; Interleukin-2 treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

CD137

2016

Completed Early Phase 1

~20

Cyclophosphamide

1995

Completed Phase 3

~3780

Fludarabine

2012

Completed Phase 3

~1100

Surgery to Remove Tumor for Growth of TIL

2016

Completed Early Phase 1

~20

TIL Infusion

2016

Completed Early Phase 1

~20

Interleukin-2

1994

Completed Phase 3

~700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,481 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,636 Previous Clinical Trials

4,127,553 Total Patients Enrolled

Prometheus Inc.Industry Sponsor

2 Previous Clinical Trials

140 Total Patients Enrolled

Frequently Asked Questions

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

How many test subjects are currently engaged in this experiment?

"Regrettably, this clinical trial is currently not recruiting. It was first advertised on March 8th 2016 and last updated on September 27th 2022. However, there are plenty of other studies available; 825 focusing on skin cancer and 1604 trials involving Nivolumab have open enrollment at the time of writing."

Answered by AI

What other investigations have been done using Nivolumab?

"Currently, there are 1604 clinical trials underway that research Nivolumab of which 243 are in the final Phase 3. While most trials take place in Philadelphia, Pennsylvania, a total of 68053 sites around the world are running studies on it."

Answered by AI

What conditions benefit most from the prescription of Nivolumab?

"Nivolumab can be deployed to treat a variety of ailments, including but not limited to: multiple sclerosis, acute and malignant neoplasms, myelocytic disorders, as well as leukemia."

Answered by AI

Is this research initiative still accepting participants?

"Unfortunately, this clinical trial is not accepting participants at the moment. According to its posting date of March 8th 2016 and latest update on September 27th 2022, it appears that recruitment has ceased. If you are in search for other studies related to cancer of the skin or Nivolumab there are presently 825 and 1604 trials respectively actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma

2016. "Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02652455.