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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

Must not have

Female patients who are pregnant or breastfeeding

Active autoimmune disease that has required systemic treatment in the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks post radiation therapy

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I have had one previous treatment with an anti-PD-1 or PD-L1 therapy.

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I have received a specific high dose radiation treatment.

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My cancer has spread to my lung, liver, or soft tissue and cannot be cured with surgery or radiation.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My cancer can be measured and tracked over time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have been treated for an autoimmune disease in the last 2 years.

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My targeted lesion has been treated with high-dose radiation before.

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I have had a stem cell transplant or an organ transplant.

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I do not have an active, uncontrolled HIV or hepatitis B/C infection.

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I have symptoms from cancer spread to my brain or its coverings.

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I have no unresolved lung or severe GI issues from past treatments.

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I've had severe reactions to previous immunotherapy or its ingredients.

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I do not have any severe illnesses that could interfere with the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks post radiation therapy

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities

Objective response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 15Eligibility criteria met