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Checkpoint Inhibitor
Chemoimmunotherapy followed by radiotherapy for Non-Small Cell Lung Cancer (RIVAL Trial)
Phase 2
Recruiting
Led By Nithya Ramnath, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately two years after enrollment
Awards & highlights
RIVAL Trial 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.Check my eligibility
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.See study design
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.
RIVAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer shows PD-L1 expression of 1% or more.
Select...
I am over 18 years old.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am eligible for treatment that combines chemotherapy and radiation.
Select...
My lung cancer is at stage III and cannot be removed by surgery.
Select...
I have a tissue sample with enough cancer cells for testing.
RIVAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately two years after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately two years after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Treatment Tolerance
Secondary outcome measures
Adverse Events
Best overall response rate (BOR)
Overall survival
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
RIVAL 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
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,259 Total Patients Enrolled
Nithya Ramnath, MDPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
8 Previous Clinical Trials
146 Total Patients Enrolled
Michael D GreenPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
1 Previous Clinical Trials
18 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many different sites is this medical study currently being administered?
"This medical research opportunity is currently open for enrollment at VA Greater Los Angeles Healthcare System in West Los Angeles, California; Hunter Holmes McGuire VA Medical Center in Richmond, Virginia; and Louis Stokes VA Medical Center in Cleveland, Ohio. Additionally, there are seven more sites where patients can participate."
Answered by AI
Are new patients currently being accepted for enrollment in this medical study?
"According to information available on clinicaltrials.gov, this specific research study is presently not open for participant recruitment. Although initially posted on 3/1/2024 and last revised on 2/16/2024, it is currently inactive in terms of enrollment. It's essential to note that amidst the broader landscape of ongoing trials, there are a substantial 1768 other studies actively seeking participants at this time."
Answered by AI
What are the safety considerations associated with combining chemotherapy, immunotherapy, and subsequent radiotherapy for individuals?
"In this Phase 2 clinical trial, the safety of chemoimmunotherapy followed by radiotherapy is rated at 2 by our team at Power, reflecting existing data on its safety but not yet on efficacy."
Answered by AI
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