NKTR-262 and NKTR-214 with or without Nivolumab in Metastatic Solid Tumors

What is the Purpose of this Study?

We are doing this study to test if the doublet and triplet study drugs are safe for patients, and also to test if they can work to slow down the growth of your tumor or make it smaller.
What is the Condition Being Studied?
Colorectal Cancer

Who Can Participate in this Study?

Adults who:

- Have diagnosed colorectal cancer

- Have had 2 anti-cancer therapies which did not work

- Have tumors large enough to be injected

Age Group
Adults
Participating Institutions

What is Involved?

If you choose to join this study you will:

- Be assigned to get either the doublet, or the triplet study drugs (like the flip of a coin)

-- In both the doublet and the triplet study drug procedures you will be given NKTR-262 by injection straight into your tumor in the clinic at Duke on Day 1 of the first 3 cycles

-- Each study cycle lasts 21 days

- You will then be given NKTR-214 in the vein over 30 minutes, after you get NKTR-262 and Opdivo in the vein (for triplet study drug participants only) over 30 minutes following NKTR-214, beginning at Cycle 1.

Study Details

Full Title
The Reveal Study: A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination with Bempegaldesleukin (NKTR-214) and in Combination with Bempegaldesleukin Plus Nivolumab in Patients with Locally Advanced or Metastatic Solid Tumor Malignancies
Principal Investigator

Contacts
Gastrointestinal Oncology DCI Clinical Research Team
Protocol Number
IRB:
PRO00094387

NCT:
NCT03435640
ClinicalTrials.gov
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