NCT03656627

Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Terminated Phase 1 Last updated 15 February 2023

What this trial tests

Phase 1 trial testing Nivolumab in Autoimmune Diseases in 7 participants. Terminated before completion.

Timeline

27 June 2019

Primary endpoint
18 March 2021

18 March 2021

Quick facts

Lead sponsor	Alliance Foundation Trials, LLC.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	27 June 2019
Primary completion	18 March 2021
Estimated completion	18 March 2021
Sites	9 locations across United States

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Autoimmune Diseases — all drugs for Autoimmune Diseases →
• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
• Psoriasis — all drugs for Psoriasis →

Sponsor

Alliance Foundation Trials, LLC.

Who can join

18 and older, any sex, with Autoimmune Diseases or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type.

Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Corticosteroids and Cancer Immunotherapy.
   Goodman RS, Johnson DB, Balko JM. · · 2023 · cited 112× · PMID 36648402 · DOI 10.1158/1078-0432.ccr-22-3181
2. PD-L1: From cancer immunotherapy to therapeutic implications in multiple disorders.
   Lee D, Cho M, Kim E, Seo Y, et al · · 2024 · cited 52× · PMID 39342430 · DOI 10.1016/j.ymthe.2024.09.026
3. The Efficacy and Safety of Immune Checkpoint Inhibitors in Patients With Cancer and Preexisting Autoimmune Disease.
   Tang H, Zhou J, Bai C. · · 2021 · cited 30× · PMID 33692958 · DOI 10.3389/fonc.2021.625872
4. Expert Perspective: Immune Checkpoint Inhibitors and Rheumatologic Complications.
   Cappelli LC, Bingham CO. · · 2021 · cited 30× · PMID 33186490 · DOI 10.1002/art.41587
5. Risk of Toxicity After Initiating Immune Checkpoint Inhibitor Treatment in Patients With Rheumatoid Arthritis.
   Efuni E, Cytryn S, Boland P, Niewold TB, et al · · 2021 · cited 30× · PMID 31977647 · DOI 10.1097/rhu.0000000000001314
6. Safety and efficacy of immune checkpoint inhibitors in advanced urological cancers with pre-existing autoimmune disorders: a retrospective international multicenter study.
   Martinez Chanza N, Xie W, Issa M, Dzimitrowicz H, et al · · 2020 · cited 25× · PMID 32217762 · DOI 10.1136/jitc-2020-000538
7. Is Timing of Steroid Exposure Prior to Immune Checkpoint Inhibitor Initiation Associated with Treatment Outcomes in Melanoma? A Population-Based Study.
   Nikita N, Banks J, Keith SW, Song A, et al · · 2022 · cited 14× · PMID 35267602 · DOI 10.3390/cancers14051296
8. Checkpoint Inhibitors in Melanoma Patients with Underlying Autoimmune Disease.
   Dietz H, Weinmann SC, Salama AK. · · 2021 · cited 9× · PMID 34754240 · DOI 10.2147/cmar.s283217