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Clinical Trial Detail

Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma

Complete title: Pembrolizumab and Neoadjuvant Radiation for Large, High-Grade Soft Tissue Sarcomas

Research Study Number 9661
 
Principal Investigator Seth Pollack
 
Phase I/II

Research Study Description

This pilot phase I/II trials studies pembrolizumab and radiation therapy in treating patients with intermediate or high-grade soft tissue sarcoma. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy may work better in treating patients with soft tissue sarcoma.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- Be willing and able to provide written informed consent for the trial

- Have measurable disease based on RECIST 1.1

- Has newly diagnosed disease (no prior chemotherapy, radiation or surgery with curative intent for this sarcoma diagnosis - prior surgery for diagnostic purposes are allowable)

- Have an intermediate- or high-grade soft tissue sarcoma according to French Federation of Cancer Centers (FNCLCC) criteria

- The tumor must be at least 5 cm in maximum dimension

- Plans to undergo neo-adjuvant radiation and surgery with curative intent

- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; if a freshly procured research specimen has already been made available to the Pollack Lab prior to consent as part of another sample collection research protocol, may be omitted with approval of the primary investigator so long as the patient has not received anti-cancer therapy or immunosuppressive therapy since the biopsy sample was collected

- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale or > 70% on the Karnofsky scale

- Absolute neutrophil count (ANC) >= 1,500/mcL, performed within 28 days of treatment initiation

- Platelets >= 100,000/mcL, performed within 28 days of treatment initiation

- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L, performed within 28 days of treatment initiation

- Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN, performed within 28 days of treatment initiation

- Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN, performed within 28 days of treatment initiation

- Albumin >= 2.5 mg/dL, performed within 28 days of treatment initiation

- International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation

- Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation

- Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

- All individuals must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject

- Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Prior radiation to affected area

- Has one of the following sarcoma subtypes where neoadjuvant chemotherapy is established as practice at our institution: extra-skeletal Ewing's sarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma (pleomorphic rhabdomyosarcoma is allowed, bone sarcomas including osteosarcoma, Ewings sarcoma and chondrosarcoma are not allowed)

- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment

- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment

- Has a known history of active TB (Bacillus tuberculosis)

- Hypersensitivity to pembrolizumab or any of its excipients

- Has had a prior, anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier

- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 28 days prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent

-- * Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study with principal investigator (PI) approval

-- * Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

- Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer

- Has current or a history of any distant metastatic disease (including brain); an isolated or oligo-metastatic regional recurrence may be allowed if all other criteria are met, curative attempt is being pursued and if PI approval is granted

- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. 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

- Has known history of, or any evidence of active, non-infectious pneumonitis

- Has an active infection requiring systemic therapy

- Has known psychiatric or substance abuse disorders that would interfere with adherence to the requirements of the trial

- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment

- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-CTLA4 or anti-PD-L2 agent

- Has a known history of human immunodeficiency virus (HIV) infection

- Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)

- Has received a live vaccine within 30 days of planned start of study therapy; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not permitted

Other exclusion criteria may apply.

Research Study Number 9661
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Sarcoma; Solid Tumors; Neoplasms, Connective and Soft Tissue; Sarcoma, Soft Tissue

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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