Is NCT04577014 recruiting in New York, NY?

Yes, NCT04577014 is currently recruiting participants at its New York, NY location. This soft tissue sarcoma clinical trial is actively enrolling qualified participants.

How do I join the soft tissue sarcoma clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Soft Tissue Sarcoma Clinical Trial in New York, NY

About This Soft Tissue Sarcoma Study in New York

This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable).

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Diagnosis of metastatic or locally advanced and unresectable high-grade soft tissue sarcoma. Unresectable is defined as:

primary tumor cannot be safely removed surgically, or

primary tumor would benefit from systemic therapy prior to a surgical approach

Be willing and able to provide written informed consent

Must consent to mandatory tumor biopsy (if deemed safe and feasible) for research studies at screening, if archival tissue is not available, and at C1D15, C3D15.

Age ≥ 18 years

ECOG performance status ≤ 1

Presence of measurable disease per RECIST v1.1

Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.

No prior systemic therapy (see

Exclusion Criteria

Negative serum pregnancy test in women of childbearing potential

Patients with chronic HBV (HBsAg-positive with undetectable or low HBV DNA and normal ALT, or HBsAg-negative with anti-HBc-positive serology) and HCV (completed curative antiviral treatment with HCV viral load below the limit of quantification) may be eligible

Patients with HBV should be treated with suppressive antiviral therapy prior to enrollment

Patients with HCV must have completed curative therapy and have negative HCV viral load

Adequate organ function, as defined in Table 2: Table 2: Laboratory Parameters Required for Study Inclusion Hematological Absolute neutrophil count (ANC): ≥ 1,500 /mcL Platelets: ≥ 75,000 / mcL Hemoglobin: ≥ 9g/dL or ≥ 5.6 mmol/L Renal Serum creatinine: ≤ 1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance: ≥ 60 mL/min for patient with creatinine levels \> 1.5 X institutional ULN (GFR can also be used in place of creatinine orCrCl) Hepatic Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN except patients with Gilbert's disease (≤ 3x ULN) AST (SGOT) and ALT (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver metastases Exclusion Criteria:

Received any systemic therapy in the advanced or metastatic setting

Adjuvant or neoadjuvant therapies received ≥ 1 year prior to enrollment are permitted

Unstable or deteriorating cardiovascular disease within the previous 6 months, including:

Unstable angina or myocardial infarction

New York Heart Association \[NYHA\] Class III or IV congestive heart failure

Uncontrolled clinically significant arrhythmias

Current use of immunosuppressive medication, EXCEPT for the following:

Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)

Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent

Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)

Evidence of clinically significant immunosuppression such as the following:

Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease

Concurrent opportunistic infection

Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 2 months prior to enrollment

History or evidence of symptomatic autoimmune disease in past 2 years prior to enrollment.

Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease

Uncontrolled HIV infection, as defined by one or more of the following:

Patients with CD4+ T-cell (CD4+) counts \< 350 cells/uL

Patients with a history of an opportunistic infection secondary to AIDS

Patients on anti-microbials with drug-drug interactions with the study drugs on this protocol, who cannot be switched to alternative anti-microbials

Patients on antiretroviral therapy \< 4 weeks

Patients with HIV viral load \> 400 copies/mL

Active Hepatitis B or Hepatitis C

Patients who have received a live vaccine within 30 days of the start date of the planned study therapy (with the exception of COVID-19 vaccines)

History of active TB (Bacillus Tuberculosis)

Radiation therapy within 2 weeks prior to study day 1

If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

Women who are pregnant or breast feeding

Patients expecting to conceive or father children within the projected duration of the trial, starting with the visit through 180 days after the last dose of study treatment(s)

Prior organ transplantation including allogenic stem-cell transplantation

Active infection requiring systemic therapy

Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)

Patients with prior history of interstitial lung disease and clinically significant pulmonary compromise, including those who have a requirement for supplemental oxygen use to maintain adequate oxygenation

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT04577014) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Soft Tissue Sarcoma Treatment Options in New York, NY

If you're searching for soft tissue sarcoma treatment options in New York, NY, this clinical trial (NCT04577014) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced soft tissue sarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all soft tissue sarcoma clinical trials near you to find additional studies recruiting in your area.

Soft Tissue Sarcoma Clinical Trial in New York, NY

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