NCT03463161: ORKA

Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy

Terminated Phase 2 Results posted Last updated 27 January 2020

What this trial tests

Phase 2 trial testing Pembrolizumab in Head and Neck Squamous Cell Carcinoma in 2 participants. Terminated before completion.

Timeline

23 March 2018

Primary endpoint
4 December 2018

4 December 2018

Quick facts

Lead sponsor	University of Chicago
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	23 March 2018
Primary completion	4 December 2018
Estimated completion	4 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Epacadostat — full drug profile →

Conditions studied

• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

University of Chicago

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Response Rate Primary · up to 18 months

Rate of clinical disease response (tumor shrinkage) as seen on imaging.

Group	Value	95% CI
Acquired Resistance or Suboptimal Benefit Group	0

Side Effects Secondary · 6 months

Number of patients with side effect. Summary of side effects by type is provided in adverse events section below.

Group	Value	95% CI
Acquired Resistance or Suboptimal Benefit Group	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Acquired Resistance or Suboptimal Benefit Group

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (6 terms — click to expand)

Reaction	System	Acquired Resistance or Sub…
Chest wall pain	Musculoskeletal and connective tissue disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Constipation	Gastrointestinal disorders	—
Neutrophil count decreased	Investigations	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—
GastGastrointestinal disorders - Other, specifyrointestinal disorders - Other, specify	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03463161 adverse events section.

Sponsor's own description

Study to determine response rate of the combination of pembrolizumab plus epacadostat in patients with head and neck cancers that have received prior immunotherapy.

Publications & conference data

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

1. Indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors in clinical trials for cancer immunotherapy.
   Tang K, Wu YH, Song Y, Yu B. · · 2021 · cited 276× · PMID 33883013 · DOI 10.1186/s13045-021-01080-8
2. Trial watch: IDO inhibitors in cancer therapy.
   Le Naour J, Galluzzi L, Zitvogel L, Kroemer G, et al · · 2020 · cited 133× · PMID 32934882 · DOI 10.1080/2162402x.2020.1777625
3. 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
4. Interactions of Indoleamine 2,3-dioxygenase-expressing LAMP3⁺ dendritic cells with CD4⁺ regulatory T cells and CD8⁺ exhausted T cells: synergistically remodeling of the immunosuppressive microenvironment in cervical cancer and therapeutic implicat
   Qu X, Wang Y, Jiang Q, Ren T, et al · · 2023 · cited 55× · PMID 37794698 · DOI 10.1002/cac2.12486
5. Targeting tumour-reprogrammed myeloid cells: the new battleground in cancer immunotherapy.
   De Sanctis F, Adamo A, Canè S, Ugel S. · · 2023 · cited 39× · PMID 36161514 · DOI 10.1007/s00281-022-00965-1
6. Interactions of IDO and the Kynurenine Pathway with Cell Transduction Systems and Metabolism at the Inflammation-Cancer Interface.
   Stone TW, Williams RO. · · 2023 · cited 38× · PMID 37296860 · DOI 10.3390/cancers15112895
7. Targeting Indoleamine Dioxygenase and Tryptophan Dioxygenase in Cancer Immunotherapy: Clinical Progress and Challenges.
   Peng X, Zhao Z, Liu L, Bai L, et al · · 2022 · cited 38× · PMID 35965963 · DOI 10.2147/dddt.s373780
8. Crosstalk Between PD-1/PD-L1 Blockade and Its Combinatorial Therapies in Tumor Immune Microenvironment: A Focus on HNSCC.
   Lin W, Chen M, Hong L, Zhao H, et al · · 2018 · cited 31× · PMID 30519541 · DOI 10.3389/fonc.2018.00532