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NG-641 + Nivolumab for Advanced Cancer (NEBULA Trial)

Phase 1
Recruiting
Led By Christian Ottensmeier, MD
Research Sponsored by PsiOxus Therapeutics Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically or cytologically documented metastatic/advanced epithelial cancer that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available
Adequate hepatic function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after last dose of study drug
Awards & highlights

NEBULA Trial Summary

This trial is testing a new drug, NG-641, to see if it is safe and effective when used with another drug, nivolumab, to treat patients with metastatic or advanced epithelial tumors.

Who is the study for?
Adults over 18 with advanced epithelial cancer that's resistant to standard treatments or without treatment options. They must have a life expectancy of at least 6 months, good organ function, and be able to follow study procedures. Exclusions include severe bleeding risks, recent other cancer therapies, certain vaccinations close to trial start, active severe infections or autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing NG-641 in combination with Nivolumab for patients with metastatic or advanced epithelial tumors. It aims to find the safest dose and see how well patients tolerate this combo therapy. The study is early stage (phase 1a/1b), open-label and not randomized.See study design
What are the potential side effects?
Possible side effects may include typical reactions related to immune therapies such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, potential liver issues (hepatitis), skin problems (rash), lung issues (pneumonitis) and an increased risk of infection.

NEBULA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or didn't respond to treatment, and there's no standard treatment left.
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My liver is working well.
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I am fully active or can carry out light work.
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I have at least one tumor that can be measured and is either not in a previously treated area or has grown despite treatment.
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I am 18 years old or older.
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My tumor can be safely biopsied, and I agree to have it done.

NEBULA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after last dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after last dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (safety and tolerability) in study of NG-641 in combination with nivolumab

NEBULA Trial Design

1Treatment groups
Experimental Treatment
Group I: IntravenousExperimental Treatment1 Intervention
Phase 1a Part A: One cycle (28 days) of NG-641 on Days 1, 3 and 5 and nivolumab on Day 15, followed by nivolumab every 4 weeks. Phase 1a Part B: NG-641 on Days 1, 3 and 5 and one nivolumab on Day 15 in each of up to eight 28-day cycles.

Find a Location

Who is running the clinical trial?

PsiOxus Therapeutics LtdLead Sponsor
11 Previous Clinical Trials
760 Total Patients Enrolled
Akamis BioLead Sponsor
11 Previous Clinical Trials
760 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,034 Total Patients Enrolled

Media Library

NG-641 in combination with Nivolumab (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05043714 — Phase 1
Cancer Research Study Groups: Intravenous
Cancer Clinical Trial 2023: NG-641 in combination with Nivolumab Highlights & Side Effects. Trial Name: NCT05043714 — Phase 1
NG-641 in combination with Nivolumab (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05043714 — Phase 1

Frequently Asked Questions

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

Is this trial pioneering a unique course of action?

"Research into the effects of NG-641 paired with Nivolumab has been conducted since Ono Pharmaceutical Co. Ltd.'s 2012 trial, which included 659 participants. Following its Phase 1 & 2 approval, there are currently 717 studies taking place in 2356 cities and 49 countries worldwide."

Answered by AI

What clinical indications are being treated with the tandem of NG-641 and Nivolumab?

"NG-641 and Nivolumab are the recommended treatments for malignant neoplasms, but they have also been found to be effective at treating other medical conditions like unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

What is the capacity of participants for this clinical experiment?

"Correct. It is apparent through the data available on clinicaltrials.gov that this medical research, posted initially on December 1st 2021, requires participants for its trial program. The study seeks to enlist 30 volunteers from a solitary clinic location."

Answered by AI

Are there still open slots for participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov indicates that this medical trial is currently accepting patients; the posting was first made on December 1st 2021 with a recent edit occurring on March 16th 2022. The research team is hoping to enroll 30 individuals from one particular site."

Answered by AI

What potential risks have been linked to the concomitant administration of NG-641 and Nivolumab?

"The safety of NG-641 combined with Nivolumab has been assessed as a 1 due to the scant evidence available, since it is an early Phase 1 trial."

Answered by AI

Could you outline the previous experimentation with NG-641 and Nivolumab?

"Currently 717 clinical trials are assessing the efficacy of NG-641 in alliance with Nivolumab, 82 of which have entered Phase 3. While several research centres based in Basel BE are running these investigations, there is a total of 40290 sites studying this combination worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours
2021. "Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05043714.
~1 spots leftby May 2024
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