← Back to Search

Checkpoint Inhibitor

NBTXR3 + Radiation and Immunotherapy for Metastatic Lung Cancer

Phase 1 & 2
Recruiting
Led By Saumil Gandhi, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One prior anti-PD-1/L1 therapy allowed
Allowed high dose RT regimens are 50 Gy in 4 fractions or 60 Gy in 10 fractions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks post radiation therapy
Awards & highlights

Study Summary

This trial is testing a combination of drugs and therapies to treat patients with solid tumors that have spread to the lung or liver. The hope is that the combination will be more effective than any one treatment alone.

Who is the study for?
Adults with advanced solid tumors that have spread to the lungs or liver may join this trial. They should have tried anti-PD-1/L1 therapy before, be in a decent physical state (ECOG 0-2), and not be pregnant or breastfeeding. Participants need functioning major organs and can't have had certain recent treatments or live vaccines, active infections, severe heart conditions, psychiatric illnesses, or specific allergies.Check my eligibility
What is being tested?
The study is testing NBTXR3 nanoparticles activated by radiation along with immunotherapy drugs against cancer that has spread to the lung/liver. It aims to see if making tumor cells more sensitive to radiation improves treatment outcomes when combined with immune system-boosting drugs.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site of NBTXR3, typical risks from radiation like skin irritation and fatigue, as well as immune-related issues such as inflammation in various organs due to Anti PD-1 / PD-L1 therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had one previous treatment with an anti-PD-1 or PD-L1 therapy.
Select...
I have received a specific high dose radiation treatment.
Select...
My cancer has spread to my lung, liver, or soft tissue and cannot be cured with surgery or radiation.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.
Select...
My cancer lesions can be treated with radiation, as confirmed by my doctor.
Select...
My cancer can be measured and tracked over time.
Select...
I can have a special injection into up to two cancer spots as decided by my doctor.
Select...
I am receiving low dose radiation therapy as specified for my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks post radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks post radiation therapy 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 dose limiting toxicities
Objective response rate

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (NBTXR3, RadScopal, Anti PD-1 / PD-L1Experimental Treatment2 Interventions
COHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) IV on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1)repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (NBTXR3, Abscopal, Anti PD-1 / PD-L1Experimental Treatment2 Interventions
COHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) intravenously (IV) on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1) repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,325 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,307 Total Patients Enrolled
Saumil Gandhi, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05039632 — Phase 1 & 2
Cancer Research Study Groups: Cohort I (NBTXR3, Abscopal, Anti PD-1 / PD-L1, Cohort II (NBTXR3, RadScopal, Anti PD-1 / PD-L1
Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05039632 — Phase 1 & 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039632 — 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 common medical conditions is Radiation Therapy prescribed to treat?

"Radiation Therapy has been demonstrated to alleviate the effects of pre-existing anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma."

Answered by AI

Is this research currently seeking participants?

"At this juncture, this medical trial is no longer seeking new patients. It was initially uploaded on March 30th 2023 and last modified August 25th 2022. However, there are still 2502 cancer studies searching for volunteers as well as 765 trials related to radiation therapy that need participants."

Answered by AI

What previous experiments have utilized Radiation Therapy to further research?

"Currently, there are 765 clinical trials being conducted which explore the efficacy of Radiation Therapy. 86 of these studies have advanced to Phase 3 and can be located at 42755 various research sites around the world – most notably in Pittsburgh, Pennsylvania."

Answered by AI

How many participants are being recruited to participate in this experiment?

"Unfortunately, this clinical trial is no longer accepting new applicants. The initial posting was on March 30th 2023 and the last update to the advertisement took place August 25th 2022. Nonetheless, there are numerous other trials actively recruiting cancer patients (2502) or radiation therapy recipients (765)."

Answered by AI
~27 spots leftby Feb 2026