What side effects are associated with this type of intervention?

Common treatments for sarcoma, such as the combination of chemotherapy (gemcitabine, doxorubicin, docetaxel) and nivolumab, are associated with a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and myelosuppression. Nivolumab, a PD-1 inhibitor, can lead to immune-related adverse events like skin rash, colitis, hepatitis, pneumonitis, and endocrinopathies. Combining these treatments may increase the risk of both chemotherapy-related and immune-related side effects, requiring careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several chemotherapy agents for the treatment of sarcoma, including doxorubicin, which is often used as a first-line treatment. Gemcitabine and docetaxel are also used, particularly in combination regimens for advanced or metastatic sarcoma. Nivolumab, a PD-1 inhibitor, has shown promise in clinical trials when combined with chemotherapy, although its use in sarcoma is still under investigation. These treatments aim to interfere with DNA replication and cell division while enhancing the immune response against cancer cells.

What other types of research exist?

Promising novel alternatives for sarcoma patients in 2024 include: 1) PARP inhibitors, especially for patients with specific genetic alterations like CDK12; 2) Combined immune checkpoint inhibitors (e.g., PD-1 inhibitors with CTLA-4 inhibitors); 3) Targeted therapies based on specific molecular characteristics of the tumor; 4) Novel combinations of immunotherapy with other agents such as kinase inhibitors or oncolytic viruses. These alternatives are under active investigation and may offer new hope for sarcoma patients.

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Taxane

Chemotherapy + Immunotherapy for Advanced Sarcoma

Q: What is the mechanism of action of this treatment?

The most common treatments for Sarcoma include chemotherapy and immunotherapy. Chemotherapy agents like gemcitabine, doxorubicin, and docetaxel interfere with DNA replication and cell division, causing cancer cell death. Nivolumab, a PD-1 inhibitor, enhances the immune response by blocking the PD-1 pathway, which cancer cells use to evade immune detection. This combination is crucial for Sarcoma patients as it directly targets cancer cells and boosts the immune system's ability to fight the cancer.

Phase 2

Recruiting

Led By Sant P Chawla, MD

Research Sponsored by Sarcoma Oncology Research Center, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma

INR and PT < 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants

Must not have

History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Sexually active subjects and their partners unwilling to use male or female latex condom.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a combination of chemotherapy and immunotherapy to treat patients with advanced sarcoma. The chemotherapy attacks the cancer directly, while the immunotherapy boosts the body's natural defenses to help fight the cancer.

Who is the study for?

This trial is for adults with advanced sarcoma that's inoperable or has spread, who understand the study and agree to follow its procedures. They must have had prior treatment, be reasonably healthy (ECOG ≤ 2), not on certain blood thinners, and have good organ function. Women of childbearing age need a negative pregnancy test and must use effective contraception.

What is being tested?

The GALLANT trial tests low-dose chemotherapy drugs Gemcitabine, Doxorubicin, Docetaxel combined with Nivolumab immunotherapy in patients with advanced sarcoma. It's an open-label phase 2 study where all participants receive the same treatment intravenously.

What are the potential side effects?

Possible side effects include fatigue, nausea, hair loss from chemotherapy drugs; immune-related issues like inflammation of organs can occur due to Nivolumab. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My sarcoma cannot be surgically removed and has spread.

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My blood clotting tests are normal or managed if I'm on blood thinners.

Select...

I can take care of myself but might not be able to do heavy physical work.

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My cancer can be measured by standard imaging tests.

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I am not pregnant and agree to use effective birth control during and after the study.

Select...

My heart pumps blood well, with an ejection fraction over 50%.

Select...

My kidney function is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am on medication for an autoimmune disease, not including hormone replacement.

Select...

I am sexually active and unwilling to use a latex condom.

Select...

I am allergic to gemcitabine, doxorubicin, docetaxel, or nivolumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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

Secondary study objectives

Adverse Events

Overall response

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Cerebral infarction

Dyspnoea

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

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: Single armExperimental Treatment4 Interventions

A total of 260 patients will receive gemcitabine 600 mg/m2 (maximum dose: 1000 mg) on D1 and D8, doxorubicin 18 mg/m2 on D1 and D8 (maximum dose: 32 mg), docetaxel 25 mg/m2 on D1 and D8 (maximum dose: 42 mg), on Days 1 and 8. After the first cycle, nivolumab 240 mg IV will be added on Day 1 of each cycle (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not complete the first 2 treatment cycles and first follow up CT scan/MRI will be replaced.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Doxorubicin

2012

Completed Phase 3

~8030

Docetaxel

1995

Completed Phase 4

~6550

Nivolumab

2014

Completed Phase 3

~5220

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sarcoma include chemotherapy and immunotherapy. Chemotherapy agents like gemcitabine, doxorubicin, and docetaxel interfere with DNA replication and cell division, causing cancer cell death. Nivolumab, a PD-1 inhibitor, enhances the immune response by blocking the PD-1 pathway, which cancer cells use to evade immune detection. This combination is crucial for Sarcoma patients as it directly targets cancer cells and boosts the immune system's ability to fight the cancer.

Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.