NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

SWOG S1512 - "A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Skin Clinical Trial

CANCER TYPE: Melanoma
RESEARCH BASE: SWOG
NCT NUMBER: NCT02775851
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM
UPDATED ON 08/16/2018 (19:17:00)

Additional Consent Form: VIEW CONSENT FORM 2
UPDATED ON 08/16/2018 (19:17:00)

BRIEF DESCRIPTION

Desmoplastic melanoma, resectable or unresectable, no prior systemic tx, short term vs long term MK-3475 (pembrolizumab).



NOTES


Treatment       (Supplied drug:  MK-3475 pembrolizumab)

Cohort A:

MK-3475 200 mg, IV, Day 1, Q 3 weeks for 3 cycles

Assessment

If progression:  1 cycle of tx, reassess, if resectable do surgery, if unresectable then off tx

If resectable do surgery

Cycle = 21 days

Cohort B:

MK-3475 200 mg, IV, Day 1, Q 3 weeks for maximum of 34 cycles

Assessment

If progression:  1 cycle of tx, reassess, if resectable do surgery, if unresectable then off tx

If resectable, physician choice of surgery or continued tx until progression

Cycle = 21 days

 

 



ELIGIBILITY

  • Cohort A: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma (see Section 12.1 for definition) that is deemed resectable.
  • Cohort B: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma (see Section 12.1 for definition) that is unresectable. Patients in Cohort B must have measurable disease per RECIST 1.1
  • Contrast-enhanced CT scans of the chest, abdomen and pelvis are required. A whole body PET/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis. Imaging of the head and neck is required only if the patient has a head/neck primary.
  • Patients must not have known brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 14 days prior to registration.
  • Patients must not have received prior systemic treatment for this melanoma.
  • Patients must not be planning to receive concomitant other biologic therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol.
  • Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration.
  • Patients may have received prior surgery. All adverse events associated with prior surgery must have resolved to ≤ Grade 1 (per CTCAE 4.0) prior to registration
  • Patients must be ≥ 18 years of age.
  • Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/mcl; platelets ≥ 50,000/mcl; and hemoglobin ≥ 8 g/dL. These results must be obtained within 28 days prior to registration.
  • Patients must have adequate liver function as evidenced by the following: total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (or ≤ 3.0 x IULN with Gilbert’s Syndrome), and AST and ALT ≤ 2.5 x IULN (or < 5 x IULN for patients with known liver metastases). These results must be obtained within 28 days prior to registration.
  • Patients must have LDH performed within 28 days prior to registration.
  • Patients must have Zubrod Performance Status ≤ 2 (see Section 10.4).
  • Patients must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Patients must not have an active infection requiring systemic therapy.
  • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patients must not have received live vaccines within 42 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Patients known to be HIV positive prior to registration are eligible if they meet the following criteria within 30 days prior to registration: stable and adequate CD4 counts (≥ 350 mm3), and serum HIV viral load of < 25,000 IU/ml. Patients must be on a stable anti-viral therapy.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated in situ cancer, adequately treated Stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration.
  • Patients must have specimens available and institutions must be planning to submit for centralized pathology review as outlined in Section 12.0 and for integrated translational medicine objectives as outlined in Section 15.1.





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