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35 Participants NeededMy employer runs this trial

Immunotherapy + SBRT for Stage IV Cancer

MB
Overseen ByMark Bernard, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mark Bernard
Must be taking: Immunotherapy
Must not be taking: Gemcitabine, Adriamycin, VEGF, BRAF inhibitors
Disqualifiers: Auto-immune diagnosis, Liver cirrhosis, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase II clinical study for people with stage IV cancer. The study will evaluate the use of stereotactic body radiation therapy (SBRT), a type of focused radiation treatment, together with immunotherapy-based treatment. SRBT will be used to treat multiple areas of cancer that have spread to other parts of the body. The study will evaluate whether this treatment approach can be safely given while patients continue their planned cancer treatment and may help control their cancer.

Are You a Good Fit for This Trial?

This trial is for adults with stage IV cancers such as cervical, esophageal, head and neck, lung, or stomach cancer. Participants must be well enough to receive both immunotherapy and focused radiation (SBRT).

Inclusion Criteria

I agree to use effective birth control during and after the study as required.
My lung cancer has a PD-L1 CPS score of 50% or higher.
My cervical cancer has a CPS score of 1 or higher, and I have not had immunotherapy before.
See 15 more

Exclusion Criteria

I do not have a serious active infection right now.
My treatment plan cannot protect my organs from excessive radiation or harm.
I have five or fewer tumors that can be treated with targeted radiation.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard-of-care immune checkpoint inhibitor therapy and concurrent stereotactic body radiation therapy (SBRT) to 6-10 metastatic lesions

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • Ipilimumab
  • Nivolumab
  • Pembrolizumab
  • Stereotactic Body Radiation Therapy (SBRT)

Trial Overview

The study tests if combining focused radiation therapy (SBRT) with immunotherapy drugs like Ipilimumab, Atezolizumab, Pembrolizumab, or Nivolumab can safely help control advanced cancers. Patients continue their usual cancer treatment while receiving these therapies.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Concurrent Immunotherapy and SBRTExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mark Bernard

Lead Sponsor

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