Study on Sunitinib and Nivolumab with Chemotherapy for Patients with Advanced Soft Tissue and Bone Sarcomas

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What is this study about?

This clinical trial is focused on studying treatments for advanced forms of soft tissue and bone sarcomas, which are types of cancer that develop in the body’s connective tissues, such as muscles, fat, and bones. The study is testing the effectiveness of two medications, Sutent (also known as sunitinib) and Opdivo (also known as nivolumab), both of which are used to treat certain types of cancer. Sutent is taken as a capsule, while Opdivo is given through an infusion into a vein. The trial also involves chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells.

The purpose of this study is to find the best dose of the combination of Sutent and Opdivo and to see how well this combination works in stopping the cancer from getting worse. The study is divided into different stages and groups, with some groups receiving different combinations of treatments. For example, one group will receive Sutent and Opdivo together, while another group will receive Opdivo with other chemotherapy drugs like epirubicin and ifosfamide. The study will also look at how safe these treatments are and how they affect the patients’ overall health.

Participants in the study will receive their assigned treatments and will be monitored over time to see how their cancer responds. The study aims to determine how long patients can live without their cancer getting worse and to assess the overall survival rate. The trial will also collect information on any side effects experienced by participants to ensure the treatments are as safe as possible. The study is expected to continue until 2025, with the goal of improving treatment options for people with advanced soft tissue and bone sarcomas.

1 initial treatment phase

The trial begins with the administration of sunitinib and nivolumab. Sunitinib is provided in the form of hard capsules, taken orally. The dosage is 12.5 mg or 25 mg, depending on the specific requirements of the trial phase.

The nivolumab is administered as a solution for infusion, which means it is given through a vein. The concentration is 10 mg/mL. The frequency and duration of administration are determined by the trial protocol.

2 dose determination

In the initial phase, the main objective is to determine the recommended dose of the sunitinib and nivolumab combination for the next phase of the trial. This involves monitoring for any adverse effects and adjusting doses as necessary.

3 efficacy evaluation

The trial then evaluates the effectiveness of the sunitinib and nivolumab combination. This is measured by the progression-free survival rate at 6 months for most patients, and at 12 months for specific cohorts.

Progression-free survival rate refers to the percentage of patients who do not experience disease progression or death within the specified timeframe.

4 cohort-specific treatment

For certain cohorts, additional combinations of medications are tested. For example, in cohort 7, the combination of epirubicin, ifosfamide, and nivolumab is used to determine the maximum tolerated dose.

In cohort 8, the combination of MAP (a chemotherapy regimen) and nivolumab is tested similarly.

5 safety and response assessment

Throughout the trial, the safety profile of the treatments is assessed. This includes monitoring the type, incidence, and severity of any adverse events.

The overall response rate is also evaluated, which is the number of patients who achieve a complete or partial response to the treatment.

6 follow-up and conclusion

After the treatment phases, patients are monitored for overall survival and any long-term effects of the treatment.

The trial is estimated to conclude by May 31, 2025, with ongoing follow-up to assess the long-term outcomes of the treatments.

Who Can Join the Study?

Patients must provide written informed consent before any study-specific procedures and agree to follow the treatment and follow-up plan.
Patients must have a confirmed diagnosis of advanced soft tissue or bone sarcomas.
Patients must have measurable disease according to RECIST 1.1 criteria, which is a standard way to measure how well a cancer treatment is working.
Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
Patients must have adequate liver, kidney, heart, and blood function.
Laboratory tests must show:
- Absolute neutrophil count (a type of white blood cell) of at least 1,200/mm³.
- Platelet count (cells that help blood clot) of at least 100,000/mm³.
- Bilirubin (a substance made by the liver) of 1.5 mg/dL or less.
- Prothrombin time (PT) and International Normalized Ratio (INR) of 1.5 or less, unless on blood thinners.
- AST and ALT (liver enzymes) of 2.5 times the upper limit of normal or less.
- Creatinine (a waste product filtered by the kidneys) of 1.5 mg/dL or less, or creatinine clearance of at least 60 ml/min.
- Calcium of 12 mg/dL or less.
Left ventricular ejection fraction (a measure of heart function) must be 50% or higher, as shown by an echocardiogram or MUGA scan.
Females of childbearing potential must have a negative pregnancy test within 24 hours before joining the study and agree to use birth control during the study and for 7 months after it ends. Patients must not be pregnant or nursing when starting the study. Both women and men of reproductive potential must agree to use effective birth control methods.
Patients must be between the ages of 12 and 80 years old, depending on the specific cohort they are in.
Patients must provide tumor tissue samples for central pathology review and research purposes.
Patients must not have received previous treatment with certain drugs, depending on the specific cohort they are in.

Who Cannot Join the Study?

Patients who have not been diagnosed with advanced soft tissue and bone sarcomas cannot participate. Sarcomas are a type of cancer that starts in tissues like muscle, fat, or bone.
Patients who are not within the specified age ranges cannot participate. The age ranges are typically defined by the study and may include children, adults, or older adults.
Patients who are not part of the specified clinical trial groups cannot participate. These groups are defined by the study and may include specific types of sarcomas or other criteria.
Patients who are not able to take the study medications, such as sunitinib, nivolumab, epirubicin, ifosfamide, doxorubicin, dacarbazine, or MAP, cannot participate. These are medications used in cancer treatment.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give informed consent, may not be eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Istituto Ortopedico Rizzoli	Bologna	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario De Leon	Leon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hjoxkcck Dj Lo Syexw Ccoo I Sgpz Pyd	Barcelona	Spain
Fkkjipzac Paby Lu Iqvlxxhfsdwap Bdbbbulni Dgt Hxukprsc Uwoifzdgjxzsc Lm Pvy	Madrid	Spain
Hiobbmqw Voec dshfeamd	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.02.2017
Spain	Not recruiting	01.02.2017

Trial locations

Investigated drugs:

Sunitinib is a medication used in this trial to help treat advanced soft tissue and bone sarcomas. It works by blocking certain proteins that promote cancer cell growth, which may help slow down or stop the progression of the cancer.

Nivolumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this trial, it is used in combination with other treatments to enhance the body’s ability to fight the cancer.

Epirubicin is a chemotherapy drug used in this trial to treat certain types of sarcomas. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Ifosfamide is another chemotherapy medication included in the trial. It is used to treat various cancers by damaging the DNA of cancer cells, which can lead to their death.

Doxorubicin is a chemotherapy drug that is part of the trial’s treatment plan for certain sarcomas. It works by disrupting the DNA inside cancer cells, which can help stop their growth.

Dacarbazine is a chemotherapy medication used in this trial to treat leiomyosarcoma. It works by slowing or stopping the growth of cancer cells.

MAP is a combination of chemotherapy drugs used in the trial. It is designed to target and kill cancer cells, helping to reduce the size of tumors and slow the progression of the disease.

Investigated diseases:

Advanced Soft Tissue and Bone Sarcomas – These are a group of cancers that originate in the connective tissues, which include muscles, fat, blood vessels, nerves, tendons, and the lining of the joints. They can occur in any part of the body but are most commonly found in the arms, legs, and trunk. The disease often begins as a painless lump or swelling and may grow over time. As the sarcoma progresses, it can invade nearby tissues and spread to other parts of the body. The progression can vary significantly depending on the specific type of sarcoma and its location. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2024-514776-40-00

Protocol code:

GEIS-52

NCT ID:

NCT03277924

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Sunitinib and Nivolumab with Chemotherapy for Patients with Advanced Soft Tissue and Bone Sarcomas

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