NCT03003637: IMCISION

ImmunoModulation by the Combination of Ipilimumab and Nivolumab Neoadjuvant to Surgery In Advanced or Recurrent Head and Neck Carcinoma

Completed Phase 1, PHASE2 Last updated 23 October 2023

What this trial tests

Phase 1, PHASE2 trial testing Nivolumab in Immunotherapy in 33 participants. Completed in 12 February 2021.

Timeline

28 February 2017

Primary endpoint
12 October 2019

12 February 2021

Quick facts

Lead sponsor	The Netherlands Cancer Institute
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	28 February 2017
Primary completion	12 October 2019
Estimated completion	12 February 2021
Sites	1 location across Netherlands

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Ipilimumab — full drug profile →

Conditions studied

• Immunotherapy — all drugs for Immunotherapy →
• Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →

Sponsor

The Netherlands Cancer Institute

Who can join

18 and older, any sex, with Immunotherapy or Head and Neck Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase IB/II trial to examine feasibility and safety of checkpoint blockade (aPD1 with or without aCTLA4) neoadjuvant to standard of care (SOC) in advanced stage head and neck squamous cell carcinoma (HNSCC), a patient population in need for improved clinical outcome and in tumors likely to respond to neoadjuvant aPD1 and aCTLA4. In addition, with this research protocol the potential impact of intratumoral hypoxia on tumor infiltrating lymphocyte (TIL) abundance, differentiation and effector function will be assessed, and the potentially divergent effects of T cell checkpoint blockade in areas of hypoxia and normoxia.

Publications & conference data

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

1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
2. Neoadjuvant immunotherapy with nivolumab and ipilimumab induces major pathological responses in patients with head and neck squamous cell carcinoma.
   Vos JL, Elbers JBW, Krijgsman O, Traets JJH, et al · · 2021 · cited 257× · PMID 34937871 · DOI 10.1038/s41467-021-26472-9
3. Combination of Ipilimumab and Nivolumab in Cancers: From Clinical Practice to Ongoing Clinical Trials.
   Kooshkaki O, Derakhshani A, Hosseinkhani N, Torabi M, et al · · 2020 · cited 95× · PMID 32580338 · DOI 10.3390/ijms21124427
4. Immunotherapy for Head and Neck Cancer: A Paradigm Shift From Induction Chemotherapy to Neoadjuvant Immunotherapy.
   Shibata H, Saito S, Uppaluri R. · · 2021 · cited 71× · PMID 34552878 · DOI 10.3389/fonc.2021.727433
5. Neoadjuvant PD-1/PD-L1 Inhibitors for Resectable Head and Neck Cancer: A Systematic Review and Meta-analysis.
   Masarwy R, Kampel L, Horowitz G, Gutfeld O, et al · · 2021 · cited 68× · PMID 34473219 · DOI 10.1001/jamaoto.2021.2191
6. Immune Evasion by Head and Neck Cancer: Foundations for Combination Therapy.
   Horton JD, Knochelmann HM, Day TA, Paulos CM, et al · · 2019 · cited 65× · PMID 30961829 · DOI 10.1016/j.trecan.2019.02.007
7. Hypermutation and microsatellite instability in gastrointestinal cancers.
   Yuza K, Nagahashi M, Watanabe S, Takabe K, et al · · 2017 · cited 65× · PMID 29340115 · DOI 10.18632/oncotarget.22783
8. Tumor microenvironment and immune-related therapies of head and neck squamous cell carcinoma.
   Qin Y, Zheng X, Gao W, Wang B, et al · · 2021 · cited 55× · PMID 33614915 · DOI 10.1016/j.omto.2021.01.011