Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Regorafenib + Nivolumab for Osteosarcoma
Phase 2
Waitlist Available
Research Sponsored by Sarcoma Alliance for Research through Collaboration
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Myelosuppressive chemotherapy: Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment
Performance Status: Lansky (≤ 16 years of age) or Karnofsky (>16 years of age) performance score of ≥ 70, or Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1. See Appendix A. Patients who are unable to walk because of paralysis, but who are up and about in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for people with a certain type of bone cancer that has returned or does not respond to treatment.
Who is the study for?
This trial is for patients aged 5 and older with high-grade osteosarcoma that's come back or hasn't responded to treatment. They need measurable disease on scans, good heart and lung function, no recent major surgeries or uncontrolled diseases, and must not be pregnant. Participants should have recovered from prior treatments and agree to use birth control.Check my eligibility
What is being tested?
The study tests the combination of Regorafenib (a cancer growth blocker) at different doses with Nivolumab (an immune system booster) in those whose osteosarcoma has resisted initial therapy. It aims to see if this combo can shrink tumors better than previous treatments.See study design
What are the potential side effects?
Regorafenib may cause liver issues, fatigue, hand-foot skin reactions, diarrhea, mouth sores; while Nivolumab might lead to immune-related side effects like inflammation in organs such as lungs or intestines, skin rash or hormone gland problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had chemotherapy that lowers blood cell counts in the last 3 weeks.
Select...
I can take care of myself and am up and about, even if I use a wheelchair.
Select...
My cancer is a high-grade osteosarcoma not linked to Paget's disease or outside the bones.
Select...
My cancer is a high-grade osteosarcoma, not linked to Paget's disease or outside the bones.
Select...
I can swallow pills whole.
Select...
My heart failure is not severe.
Select...
I can take care of myself and do most of my daily activities.
Select...
My osteosarcoma has returned or didn't respond after initial treatment.
Select...
My osteosarcoma has returned or didn't respond after initial treatment.
Select...
My liver function tests are within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare the 4-month progression-free survival rate to historical controls
Secondary outcome measures
Describe adverse events
Estimate 1-year and 2-year Overall Survival
Objective Response Rate
+2 moreSide 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%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
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%
Musculoskeletal chest pain
5%
Malaise
5%
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%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Regorafenib and NivolumabExperimental Treatment3 Interventions
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?
Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,906 Total Patients Enrolled
3 Trials studying Osteosarcoma
223 Patients Enrolled for Osteosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken a medication that is still being tested in research within the last 28 days before joining this study.I am taking warfarin for blood thinning.My lungs are working well.I haven't had major surgery or serious injuries in the last 28 days.I haven't had chemotherapy that lowers blood cell counts in the last 3 weeks.My heart is functioning well.I had treatment for brain metastases and have shown no signs of worsening for 4 weeks.I have had a serious blood clot that needed blood thinners in the last 6 months.My cancer is a high-grade osteosarcoma not linked to Paget's disease or outside the bones.I can take care of myself and am up and about, even if I use a wheelchair.It has been over a week since my last biologic (cancer) treatment.It has been over 2 months since my last stem cell transplant or cellular therapy.Your hemoglobin level is at least 8 grams per deciliter, and you are allowed to receive blood transfusions if needed.I am 5 years old or older.I have not received a live vaccine in the last 30 days.I am taking or need strong medication that affects liver enzymes.I have had a bowel perforation or developed a fistula in the past.I have a tumor that can be measured on a scan, taken within the last 21 days.I have been treated with drugs targeting the immune system or blood vessel growth.I am at least 5 years old.My cancer is a high-grade osteosarcoma, not linked to Paget's disease or outside the bones.I can swallow pills whole.My heart failure is not severe.You have an autoimmune disease.I haven't had a heart attack, stroke, or serious heart rhythm problems in the last 6 months.I am not pregnant or nursing.It's been enough time since my last radiation therapy as required.I have a severe gut condition causing major diarrhea.I agree to use effective birth control during and after the study as required.I have not had severe bleeding in the last 28 days.My body surface area is less than 0.4 square meters.I have fluid in my chest or abdomen causing significant breathing problems.It's been over a week since I last received treatment to boost my white blood cells or platelets, and over two weeks since my last pegfilgrastim dose.My organs and bone marrow are functioning well.Any side effects from my previous treatments are mild or stable.I have had a stem cell or organ transplant in the past.I am allergic to ingredients in regorafenib, nivolumab, or similar drugs.I can take care of myself and do most of my daily activities.My osteosarcoma has returned or didn't respond after initial treatment.I have a tumor that can be measured on a scan, taken within the last 21 days.I regularly take medication that weakens my immune system.My osteosarcoma has returned or didn't respond after initial treatment.You have enough platelets in your blood (at least 75,000 per cubic millimeter).I have been diagnosed with active HIV.My blood pressure is not controlled by medication.I am over 18 and agree to have tumor biopsies for the study, or I have an exception approved by the study leader.I don't have another cancer that could affect this trial's safety or results.It has been over 3 weeks since I last received treatment with a monoclonal antibody.You have a sufficient amount of a type of white blood cell called neutrophils.I have a wound, ulcer, or fracture that is not healing.I do not have any infections that are not responding to treatment.My liver function tests are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Regorafenib and Nivolumab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What research has been conducted involving Nivolumab besides this current study?
"Presently, 87 Phase 3 trials studying Nivolumab are ongoing with 762 total clinical studies taking place. Basel, BE is home to many of the trialling locations while a total of 41032 sites worldwide have recruited participants for this research."
Answered by AI
Is this an innovative clinical trial?
"Nivolumab has been the subject of numerous studies since its initial trial in 2012, sponsored by Ono Pharmaceutical Co. Ltd. The Phase 1 and 2 drug approval was granted following 659 participants being trialled. At present, there are 762 clinical trials for Nivolumab around the globe with locations in 50 countries spread across 2448 cities."
Answered by AI
How many participants are being recruited for this research endeavor?
"To complete this trial, 48 participants that satisfy the eligibility requirements must be admitted. Potential enrollees can access these services at UT Southwestern Medical Center in Dallas and Johns Hopkins Hospital in Baltimore."
Answered by AI
What is the regular application of Nivolumab in medical practice?
"Nivolumab is often employed to treat malignant neoplasms, and it has also been found useful for managing unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Is this investigation currently enrolling individuals?
"Affirmative. Clinicaltrials.gov has registered that this trial, originally published on June 4th 2021, is still accepting recruits. 48 individuals are sought out from 9 distinct clinical sites."
Answered by AI
To what extent does Nivolumab pose a hazard to individuals?
"With limited clinical data available to prove Nivolumab's efficacy, the safety rating for this drug was assigned a 2."
Answered by AI
What is the geographic scope of this experiment?
"Nine medical centres are involved in this clinical trial. Participating locations include UT Southwestern Medical Center (Dallas), Johns Hopkins (Baltimore) and University of Miami (Miami). Additionally, there is a handful of other sites contributing to the study."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger