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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Expansion Cohort 2: Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve)
Biopsy-confirmed cancer diagnosis indicated to receive anti-PD-1 therapy
Must not have
Locoregional recurrent HNSCC with ulceration
History of immune-related adverse events related to administration of anti-PD-1/L1 that led to the termination of the previous anti-PD-1 therapy due to intolerance or toxicity and precludes further PD-1 exposure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment that involves injecting a drug directly into tumors and combining it with anti-PD-1 therapy. The goal is to see if this is a safe and effective treatment for cancer.
Who is the study for?
This trial is for adults with advanced cancers like lung, kidney, bladder, skin cancer and more who have a life expectancy over 12 weeks. They must be able to receive radiotherapy and not have had certain treatments recently or suffer from conditions like severe heart failure or active infections.
What is being tested?
The study tests NBTXR3 injected into tumors activated by radiotherapy alongside anti-PD-1 therapy (Pembrolizumab or Nivolumab). It's an open-label Phase I trial meaning everyone gets the treatment and doctors know what they're giving.
What are the potential side effects?
Possible side effects include reactions at the injection site, typical chemotherapy effects such as fatigue, nausea, inflammation due to immune response changes. Radiotherapy may cause skin irritation or other localized issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never received anti-PD-1 therapy.
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My cancer diagnosis was confirmed by a biopsy and is recommended for anti-PD-1 therapy.
Select...
My cancer has spread to a part of my lung that hasn't been treated with radiation.
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You have a tumor in a certain location in the body that may or may not have been treated with radiation before.
Select...
My cancer has spread to a part of my liver that hasn't been treated with radiation.
Select...
I have head, neck, lung, or liver cancer that can't be removed by surgery but can be treated with radiation.
Select...
My cancer has spread and I have at least one tumor that can be targeted with radiation.
Select...
I was treated with anti-PD-1 therapy but it stopped working.
Select...
I have had anti-PD-1 therapy before and it did not work for me.
Select...
I have had anti-PD-1 therapy and it didn't work as expected.
Select...
I have a tumor that can be measured and is accessible for direct injection.
Select...
You have a specific type of cancer that has spread, and you have at least one specific type of lesion that can be treated with radiation therapy.
Select...
I have never received anti-PD-1 therapy.
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My tumor cannot be removed surgically and is in a previously treated area but can be re-irradiated.
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I can take care of myself and perform daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My head or neck cancer has come back in the same area and has caused an open sore.
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I had severe side effects from previous anti-PD-1 cancer therapy, stopping further use.
Select...
I have had pneumonitis treated with steroids or have it now.
Select...
I have HIV or active hepatitis B/C.
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I have symptoms from cancer spread to my brain or its coverings.
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My cancer has spread to more than 5 areas including the original tumor site.
Select...
I have serious heart rhythm problems.
Select...
I am not pregnant or nursing and willing to use contraception if of child-bearing potential.
Select...
I am currently receiving IV antibiotics for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
[Dose Escalation Part]: Determination of the Recommended Dose
[Dose Expansion Part]: Safety Evaluation at RP2D
Secondary study objectives
Assessment of the safety and feasibility of R3/RT/PD-1
Evaluation of the anti-tumor response of R3/RT/PD-1
Evaluation of the body kinetic profile of intratumorally injected NBTXR3
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NBTXR3 activated by SABR followed by anti-PD-1 monotherapyExperimental Treatment4 Interventions
Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
SABR
2012
Completed Phase 2
~110
Pembrolizumab
2017
Completed Phase 3
~3150
NBTXR3
2011
Completed Phase 3
~210
Find a Location
Who is running the clinical trial?
NanobiotixLead Sponsor
6 Previous Clinical Trials
805 Total Patients Enrolled
Elsa Borghi, MDStudy DirectorNanobiotix
Pavel Tyan, MDStudy DirectorNanobiotix
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My head or neck cancer has come back in the same area and has caused an open sore.I have never received anti-PD-1 therapy.My cancer diagnosis was confirmed by a biopsy and is recommended for anti-PD-1 therapy.My cancer has spread to a part of my lung that hasn't been treated with radiation.You have a tumor in a certain location in the body that may or may not have been treated with radiation before.I had severe side effects from previous anti-PD-1 cancer therapy, stopping further use.I have been treated for an autoimmune disease in the last year.I have had pneumonitis treated with steroids or have it now.You are expected to live for more than 12 weeks.Women who could become pregnant must have a negative pregnancy test within 7 days before receiving the NBTXR3 injection.My cancer has spread to a part of my liver that hasn't been treated with radiation.I have head, neck, lung, or liver cancer that can't be removed by surgery but can be treated with radiation.My cancer has spread and I have at least one tumor that can be targeted with radiation.I have HIV or active hepatitis B/C.I have symptoms from cancer spread to my brain or its coverings.I have not received a live virus vaccine in the last 30 days.I have not had cancer treatment or experimental drugs in the last 4 weeks.My cancer has spread to more than 5 areas including the original tumor site.I have serious heart rhythm problems.My heart's ability to pump blood is significantly impaired.I am not pregnant or nursing and willing to use contraception if of child-bearing potential.I was treated with anti-PD-1 therapy but it stopped working.I have had anti-PD-1 therapy before and it did not work for me.I have had anti-PD-1 therapy and it didn't work as expected.I have a tumor that can be measured and is accessible for direct injection.I still have side effects from cancer treatment that are not mild.I am currently receiving IV antibiotics for an infection.You have a specific type of cancer that has spread, and you have at least one specific type of lesion that can be treated with radiation therapy.I have never received anti-PD-1 therapy.My organs and bone marrow are working well.I received checkpoint inhibitor therapy less than 2 weeks before NBTXR3 injection.For Expansion Cohorts 1 and 3, you have received a certain type of treatment and it did not work well. For Expansion Cohort 2, you have not received this treatment before.My tumor cannot be removed surgically and is in a previously treated area but can be re-irradiated.I can take care of myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: NBTXR3 activated by SABR followed by anti-PD-1 monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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