Melanoma Clinical Trial

NL-201 Monotherapy and in Combination With Pembrolizumab in Patients With Relapsed or Refractory Cancer

Summary

Parts 1 and 2 The primary purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing. In Part 1, there will be backfill cohorts at certain DMC-cleared dose levels and schedules to collect PK, PD and response data in certain tumor types or to explore additional pre-medication regimens.

Parts 3 and 4 The primary purpose of this study is to understand the safety of NL-201 in combination with pembrolizumab when both drugs are given intravenously in patients with advanced cancer, to evaluate tolerability, and to identify a recommended dose and schedule for further testing.

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Full Description

Patients will have tests and exams to see if they are eligible for the clinical trial.

Parts 1 and 2 If eligible, the patient will receive NL-201 treatment by vein. Tumor response to treatment will be assessed every 6 weeks for 12 weeks, and every 12 weeks thereafter until disease progression.

Patients will be able to receive study treatment as long as it is tolerated and there is evidence of clinical benefit. Safety follow-up will occur within 7 days after the last dose of NL-201. Patients will then enter long-term follow-up until starting a subsequent therapy.

In Part 1, there will be backfill cohorts at certain DMC-cleared dose levels and schedules to collect PK, PD and response data in certain tumor types or to explore additional pre-medication regimens.

Parts 3 and 4 If eligible, the patient will receive NL-201 and pembrolizumab treatment by vein. Tumor response to treatment will be assessed every 6 weeks for 12 weeks, and every 12 weeks thereafter until disease progression.

Patients will be able to receive study treatments as long as they are tolerated and there is evidence of clinical benefit. Safety follow-up will occur within 7 days after the last dose of investigational product. Patients will then enter long-term follow-up until starting a subsequent therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients with measurable disease
Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
At least 6 weeks from any prior nitrosurea or mitomycin C therapy; at least 4 weeks from any other prior chemotherapy or checkpoint inhibitor; at least 2 weeks from any kinase inhibitor
Part 1 Only: Patients with relapsed or refractory advanced solid tumor, other than prostate cancer, who have progressed, not tolerated or are ineligible for all approved lines of therapy
Part 2 Only: Patients with kidney and skin cancer who have failed at least 1 line of systemic therapy
Part 3 Only: Patients with solid tumors who have received ≥ 1 prior line of therapy for advanced or metastatic disease
Part 4 Only: Patients with diagnosed target disease OR previously received pembrolizumab

Exclusion Criteria:

Prostate Cancer
Any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in the opinion of the Investigator) would preclude protocol adherence or would make the safety of the study drug difficult to assess
Known or suspected SARS-CoV-2 infection, unless patient tests negative for SARS-CoV-2 within the Screening period
History of solid organ transplant or bone marrow transplant
Prior CAR-T or allogeneic cellular therapy
Prior IL-2-based cancer therapy
Ongoing systemic immunosuppressive therapy
Concurrent therapy with any other investigational agent, vaccine, or device.
Part 3 and 4 Only: History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Part 3 and 4 Only: Known additional cancer that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone curative resection are eligible.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

310

Study ID:

NCT04659629

Recruitment Status:

Active, not recruiting

Sponsor:

Neoleukin Therapeutics, Inc.

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There are 13 Locations for this study

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Mayo Clinic Scottsdale/ Phoenix
Phoenix Arizona, 85054, United States
City of Hope
Duarte California, 91010, United States
UCLA
Los Angeles California, 90095, United States
UC San Diego Moores Cancer Center
San Diego California, 92037, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Westchester Medical Center
Valhalla New York, 10595, United States
Providence Cancer Center Oncology and Hematology Care Clinic
Portland Oregon, 97213, United States
UT- MD Anderson
Houston Texas, 77230, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City Utah, 80045, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Melanoma Institute Australia
Sydney New South Wales, 2065, Australia
St Vincents Hospital
Sydney New South Wales, , Australia
Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg Victoria, , Australia
Cabrini Hospital Malvern
Malvern Victoria, , Australia
UHN - Princess Margaret Cancer Center
Toronto Ontario, M5G1Z, Canada

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

310

Study ID:

NCT04659629

Recruitment Status:

Active, not recruiting

Sponsor:


Neoleukin Therapeutics, Inc.

How clear is this clinincal trial information?

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