← Back to Search

Checkpoint Inhibitor

Nivolumab +/- rHuPH20 for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types: Metastatic squamous or non-squamous NSCLC, RCC, advanced or metastatic, Melanoma, HCC, CRC, metastatic (MSI-H or dMMR), In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor, In Part E, Metastatic urothelial carcinoma, Measurable disease as per RECIST version 1.1 criteria, ECOG performance status of 0 or 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Study Summary

This trial will look at the effects of nivolumab given under the skin, with or without rHuPH20, on participants with advanced or metastatic tumors.

Who is the study for?
This trial is for adults with certain advanced tumors: non-small cell lung cancer, renal cell carcinoma, melanoma, liver cancer, colorectal cancer (with specific genetic features), and possibly others including metastatic urothelial carcinoma. Participants must have measurable disease and be in good physical condition (able to perform daily activities without significant limitations).Check my eligibility
What is being tested?
The study tests the effectiveness of Nivolumab, an immunotherapy drug given under the skin alone or combined with rHuPH20. It's aimed at treating various types of advanced cancers that are approved for Nivolumab monotherapy.See study design
What are the potential side effects?
Nivolumab can cause immune-related side effects such as inflammation in organs like lungs or intestines, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 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
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Maximum observed serum concentration (Cmax)
Observed serum concentration at the end of a dosing interval (Ctau)
+2 more
Secondary outcome measures
Incidence of AEs in the broad standardized MedDRA queries (SMQ) of Anaphylactic Reaction
Incidence of AEs leading to deaths
Incidence of AEs leading to discontinuation
+17 more

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455
38%
Fatigue
37%
Diarrhoea
37%
Pruritus
29%
Headache
28%
Rash
24%
Hypothyroidism
24%
Nausea
20%
Hyperthyroidism
18%
Arthralgia
18%
Cough
18%
Asthenia
15%
Alanine aminotransferase increased
13%
Lipase increased
13%
Pyrexia
12%
Constipation
12%
Aspartate aminotransferase increased
12%
Decreased appetite
12%
Nasopharyngitis
11%
Abdominal pain
11%
Dry mouth
11%
Vomiting
11%
Myalgia
10%
Hypophysitis
10%
Insomnia
10%
Back pain
9%
Amylase increased
8%
Dyspnoea
8%
Upper respiratory tract infection
7%
Dizziness
6%
Adrenal insufficiency
6%
Abdominal pain upper
6%
Infusion related reaction
6%
Hyperglycaemia
6%
Oropharyngeal pain
6%
Blood creatine phosphokinase increased
6%
Influenza like illness
5%
Vitiligo
5%
Hypertension
5%
Pain in extremity
3%
Colitis
3%
Anxiety
2%
Immune-mediated enterocolitis
2%
Autoimmune hepatitis
2%
Basal cell carcinoma
2%
Malignant neoplasm progression
1%
Autoimmune colitis
1%
Squamous cell carcinoma
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Erysipelas
1%
Pneumonia
1%
Melanoma recurrent
1%
Pneumonitis
1%
Sarcoidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Ipi
Arm B: Nivo

Trial Design

7Treatment groups
Experimental Treatment
Group I: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20Experimental Treatment2 Interventions
Group II: Part D, Group 5: nivolumab (dose 3) + rHuPH20Experimental Treatment2 Interventions
Group III: Part C: nivolumab (dose 3) + rHuPH20Experimental Treatment2 Interventions
Group IV: Part B, Group 4: nivolumab (dose 2)Experimental Treatment1 Intervention
Group V: Part B, Group 3: nivolumab (dose 2) + rHuPH20Experimental Treatment2 Interventions
Group VI: Part B, Group 2: nivolumab (dose 1)Experimental Treatment1 Intervention
Group VII: Part A, Group 1: nivolumab (dose 1) + rHuPH20Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960
rHuPH20
2008
Completed Phase 2
~650

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,374 Total Patients Enrolled
12 Trials studying Tumors
2,128 Patients Enrolled for Tumors

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03656718 — Phase 1 & 2
Tumors Research Study Groups: Part A, Group 1: nivolumab (dose 1) + rHuPH20, Part B, Group 4: nivolumab (dose 2), Part B, Group 3: nivolumab (dose 2) + rHuPH20, Part B, Group 2: nivolumab (dose 1), Part C: nivolumab (dose 3) + rHuPH20, Part D, Group 5: nivolumab (dose 3) + rHuPH20, Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
Tumors Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03656718 — Phase 1 & 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03656718 — Phase 1 & 2

Frequently Asked Questions

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

What do clinicians commonly prescribe nivolumab for?

"Nivolumab is commonly used to treat cancerous tumours, such as malignant melanoma, squamous cell carcinoma, and drug extravasation."

Answered by AI

Are there numerous locations in the US offering this clinical research opportunity?

"The trial is currently enrolling patients from 9 distinct sites, including Greenville, Tyler and Rockville. To reduce the burden of travel for potential participants, we recommend selecting a location closest to you."

Answered by AI

Is this trial the inaugural attempt at testing these treatments?

"Currently, there are 752 active trials for nivolumab in 2499 cities and 57 countries. The initial trial of this drug was sponsored by Ono Pharmaceutical Co. Ltd., began in 2012 with 659 participants, and concluded its Phase 1 & 2 clinical stages that year. Since then, 295 additional studies have been finalized."

Answered by AI

What is the aggregate amount of participants in this clinical trial?

"Currently, this clinical trial is not taking in new participants. Initially posted on October 31st 2018 and modified most recently on November 18th 2022, if you are curious about other trials there are 25 medical studies currently recruiting for neoplasms by site and 752 more concerning nivolumab that have open enrollment periods."

Answered by AI

Does this research still have open enrollment?

"At this time, no further recruitment is taking place for this particular study. The first posting of the trial was on October 31st 2018 and the last update made to it was November 18th 2022. For those searching for additional trials, there are 25 studies recruiting patients with neoplasms by site and 752 studies actively seeking participants for nivolumab treatment."

Answered by AI

What prior experiments have examined the efficacy of nivolumab?

"752 clinical trials related to nivolumab are currently being conducted across the world, 94 of which have reached Phase 3. Most studies for this medication occur in Strasbourg; however, 43122 other locations are also running similar experiments."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
2018. "A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03656718.
~22 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top