ClinicalTrials.gov

History of Changes for Study: NCT04616196
A Phase 1b/2 Study of NKTR 255 in Combination With Cetuximab in Solid Tumors
Latest version (submitted March 31, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 October 30, 2020 None (earliest Version on record)
2 November 13, 2020 Study Status, Contacts/Locations and Study Identification
3 December 3, 2020 Contacts/Locations and Study Status
4 December 22, 2020 Study Status and Contacts/Locations
5 February 8, 2021 Study Status
6 February 22, 2021 Contacts/Locations and Study Status
7 February 26, 2021 Contacts/Locations and Study Status
8 March 16, 2021 Study Status and Contacts/Locations
9 April 19, 2021 Study Status
10 April 28, 2021 Contacts/Locations and Study Status
11 May 13, 2021 Contacts/Locations and Study Status
12 June 25, 2021 Study Status and Contacts/Locations
13 July 9, 2021 Study Status and Contacts/Locations
14 July 28, 2021 Contacts/Locations and Study Status
15 August 24, 2021 Study Status
16 August 31, 2021 Contacts/Locations and Study Status
17 September 17, 2021 Study Status and Contacts/Locations
18 October 26, 2021 Study Status
19 December 21, 2021 Arms and Interventions, Outcome Measures, Study Status, Conditions, Study Description, Contacts/Locations, Eligibility, Study Design and Study Identification
20 January 14, 2022 Study Status and Contacts/Locations
21 February 28, 2022 Study Status
22 March 31, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT04616196
Submitted Date:  October 30, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 19-255-03
Brief Title: A Phase 1b/2 Study of NKTR 255 in Combination With Cetuximab in Solid Tumors
Official Title: A Phase 1b/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR 255 in Combination With Cetuximab as a Salvage Regimen for Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Recruiting
Study Start: October 30, 2020
Primary Completion: April 2022 [Anticipated]
Study Completion: April 2023 [Anticipated]
First Submitted: October 30, 2020
First Submitted that
Met QC Criteria:
October 30, 2020
First Posted: November 4, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 30, 2020
Last Update Posted: November 4, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Nektar Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Patients with relapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal carcinoma (CRC) will receive a loading dose of cetuximab alone, followed 7 days later by the first combination treatment of cetuximab and NKTR-255 on Cycle 1 Day 1 (C1D1). Thereafter, intravenous (IV) NKTR-255 will be given in 21-day cycles in combination with weekly IV cetuximab. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255 in combination with cetuximab, this dose of NKTR-255 will be further studied in patients with HNSCC (Cohort A) and CRC (Cohort B) in Phase 2 of the study.
Detailed Description:

This study is a Phase 1b/2, open-label, multicenter dose escalation and dose expansion study in patients with R/R HNSCC or CRC.

NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects.

After an initial cetuximab loading dose during the study run-in period (Day -7), patients will receive IV NKTR-255 every 21 days in combination with cetuximab weekly. In the dose escalation phase, beginning with Dose Level 1, successive cohorts will receive ascending doses of NKTR-255 until the MTD and/or RP2D is determined. Patients who achieve optimal response (partial response or complete response), will be given the option to continue treatment with NKTR-255 as single agent for maintenance.

Enrollment into Phase 2 will commence once the RP2D is established in Phase 1b. The RP2D of NKTR-255 will be evaluated in expansion Cohorts A and B. Cohort A will combine NKTR-255 and cetuximab in patients with R/R HNSCC and Cohort B will combine NKTR-255 and cetuximab in patients with R/R CRC.

Open or close this module Conditions
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Colorectal Cancer (CRC)
Keywords: HNSCC
CRC
R/R
NKTR-255
Cetuximab
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Phase 1: Dose escalation cohorts will be sequential Phase 2: Cohorts A and B will be in parallel
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 78 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Dose Escalation of NKTR-255 with Cetuximab
Establish RP2D, of NKTR-255 with cetuximab.
Drug: NKTR-255
After the loading dose of cetuximab, NKTR-255 IV, every 21 days with cetuximab weekly.
Other Names:
  • Cetuximab
Experimental: Dose expansion of NKTR-255 with Cetuximab
The RP2D of NKTR-255 will be evaluated in expansion Cohorts A and B.
Drug: NKTR-255
Cohort A will combine NKTR-255 and cetuximab in patients with R/R HNSCC and Cohort B will combine NKTR-255 and cetuximab in patients with R/R CRC. Each cycle of NKTR-255 will be 21 days, and cetuximab will be given weekly.
Other Names:
  • Cetuximab
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 with Cetuximab
[ Time Frame: 60 days after the last dose of study treatment. ]

Safety and tolerability of NKTR-255 in combination with cetuximab as evaluated by dose limiting toxicities, incidence of drug-related Adverse Events (AEs), SAEs, and AEs leading to discontinuation, deaths, and clinical laboratory abnormalities per CTCAE 5.0
2. Efficacy of NRTR-255 with Cetuximab
[ Time Frame: Through study completion, an expected average of 1 year ]

Efficacy of NKTR-255 in combination with cetuximab in R/R metastatic HNSCC or CRC by assessing the objective response rate (ORR) by RECIST 1.1
Secondary Outcome Measures:
1. Efficacy of NKTR-255 with Cetuximab
[ Time Frame: Through study completion, an expected average of 1 year ]

Evaluate the anti-tumor activity of the combination of NKTR-255 and cetuximab by assessing progression-free survival (PFS) and overall survival (OS).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of a locally advanced or metastatic HNSCC or CRC.
  • Life expectancy > 12 weeks as determined by the Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Measurable disease per RECIST 1.1.

HNSCC: Progression on any first or second line platinum-based chemotherapy and/or anti-PD-1 or programmed death-ligand 1 antibody.

CRC: Patients must have received or were intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease.

CRC: Patients with microsatellite instability-high (MSI-H) or mismatched repair disease (dMMR) tumors must have been exposed to checkpoint inhibitors such as anti-PD-(L)1 or anticytotoxic T-lymphocyte-associated protein (CTLA)-4 antibody.

Key Exclusion Criteria:

  • Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s)
  • Prior surgery or radiotherapy within 14 days of initiating study drug(s)
  • Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis; active infection requiring systemic therapy within 7 days prior to dosing
  • Patients who have been previously treated with IL-2 or IL-15
  • Contraindication to or unable to receive cetuximab
Open or close this module Contacts/Locations
Central Contact Person: Nektar Recruitment
Telephone: 855-482-8676
Email: StudyInquiry@nektar.com
Central Contact Backup: Praveena Raman
Telephone: 415-961-2321
Email: praman@nektar.com
Study Officials: Mario Marcondes, MD PhD
Study Director
Nektar Therapeutics
Locations: United States, California
UC San Diego
[Not yet recruiting]
San Diego, California, United States, 92103
UC San Francisco
[Not yet recruiting]
San Francisco, California, United States, 94158
United States, Illinois
University of Chicago
[Not yet recruiting]
Chicago, Illinois, United States, 60637
United States, Michigan
Karmanos Cancer Center
[Not yet recruiting]
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota
[Not yet recruiting]
Minneapolis, Minnesota, United States, 55455
United States, Montana
St. Vincent Health Care
[Not yet recruiting]
Billings, Montana, United States, 59101
United States, New York
Memorial Sloan Kettering Cancer Center
[Not yet recruiting]
New York, New York, United States, 10065
United States, Texas
Mary Crowley Cancer Research
[Not yet recruiting]
Dallas, Texas, United States, 75230
MD Anderson Cancer Center
[Not yet recruiting]
Houston, Texas, United States, 77030
START Center for Cancer Care
[Recruiting]
San Antonio, Texas, United States, 78229
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services