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Checkpoint Inhibitor

Immunotherapy for Lung Cancer (RIVAL Trial)

Phase 2
Recruiting
Led By Michael D Green
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PD-L1 tumor expression greater than or equal to 1%
Participants must be more than 18 years of age
Must not have
Active autoimmune disease that has required immunosuppressive therapy in the previous year
Baseline corticosteroid usage (>10 mg prednisone or equivalent daily) aside from supportive medication use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately two years after enrollment
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a combination of chemotherapy and immunotherapy followed by radiotherapy to see how safe and effective it is for patients with advanced lung cancer that cannot be surgically removed."

Who is the study for?
This trial is for veterans with Stage III NSCLC that can't be removed by surgery. Participants should meet certain health standards, but specific inclusion and exclusion criteria are not listed.
What is being tested?
The study tests the combination of chemotherapy and immunotherapy (Nivolumab), followed by radiotherapy to treat patients with advanced lung cancer that cannot be surgically removed.
What are the potential side effects?
Possible side effects include immune-related reactions affecting various organs, fatigue, skin issues, infusion reactions, potential lung inflammation from radiotherapy, and typical chemotherapy side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer shows PD-L1 expression of 1% or more.
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I am over 18 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am eligible for treatment that combines chemotherapy and radiation.
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My lung cancer is at stage III and cannot be removed by surgery.
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I have a tissue sample with enough cancer cells for testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune disease and have taken immunosuppressive drugs in the last year.
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I take more than 10 mg of prednisone or its equivalent daily, not including medication for symptom relief.
Select...
I have been diagnosed with Interstitial Lung Disease.
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My tumor has specific genetic changes (EGFR, ALK, ROS1, MET, RET).
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I do not have uncontrolled HIV or a similar immune condition.
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I have had chest radiation or treatment for advanced lung cancer before.
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I have a history of active tuberculosis.
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I have an active Hepatitis B or C infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately two years after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately two years after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival
Treatment Tolerance
Secondary study objectives
Adverse Events
Best overall response rate (BOR)
Overall survival

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

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: Chemoimmunotherapy followed by radiotherapyExperimental Treatment1 Intervention
Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,765,751 Total Patients Enrolled
Michael D GreenPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
1 Previous Clinical Trials
18 Total Patients Enrolled
Nithya Ramnath, MDPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
8 Previous Clinical Trials
146 Total Patients Enrolled
~17 spots leftby Feb 2027
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