NCT02658214

Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors

Completed Phase 1 Last updated 20 August 2020

What this trial tests

Phase 1 trial testing paclitaxel + carboplatin in Small Cell Lung Carcinoma in 32 participants. Completed in 14 November 2019.

Timeline

28 April 2016

Primary endpoint
14 November 2019

14 November 2019

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	28 April 2016
Primary completion	14 November 2019
Estimated completion	14 November 2019
Sites	6 locations across Japan, South Korea

Drugs / interventions tested

• paclitaxel + carboplatin
• carboplatin + etoposide — full drug profile →
• gemcitabine + carboplatin — full drug profile →
• nab-paclitaxel (paclitaxel-albumin) + carboplatin
• oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
• durvalumab — full drug profile →
• tremelimumab (TREMELIMUMAB) — full drug profile →
• nab-paclitaxel (paclitaxel-albumin) + gemcitabine
• cisplatin + 5-fluorouracil (5FU)

Conditions studied

• Small Cell Lung Carcinoma — all drugs for Small Cell Lung Carcinoma →
• Carcinoma, Squamous Cell of Head and Neck — all drugs for Carcinoma, Squamous Cell of Head and Neck →
• Stomach Neoplasms — all drugs for Stomach Neoplasms →
• Triple Negative Breast Neoplasms — all drugs for Triple Negative Breast Neoplasms →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 99, any sex, with Small Cell Lung Carcinoma or Carcinoma, Squamous Cell of Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer, PDAC, ESCC.

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. Immunotherapeutic approaches for small-cell lung cancer.
   Iams WT, Porter J, Horn L. · · 2020 · cited 237× · PMID 32055013 · DOI 10.1038/s41571-019-0316-z
3. Durvalumab: First Global Approval.
   Syed YY. · · 2017 · cited 130× · PMID 28643244 · DOI 10.1007/s40265-017-0782-5
4. Prognostic significance of tumor immune microenvironment and immunotherapy: Novel insights and future perspectives in gastric cancer.
   Lazăr DC, Avram MF, Romoșan I, Cornianu M, et al · · 2018 · cited 114× · PMID 30166856 · DOI 10.3748/wjg.v24.i32.3583
5. New Strategies in Breast Cancer: Immunotherapy.
   Pusztai L, Karn T, Safonov A, Abu-Khalaf MM, et al · · 2016 · cited 108× · PMID 26867935 · DOI 10.1158/1078-0432.ccr-15-1315
6. Immunotherapeutic interventions of Triple Negative Breast Cancer.
   Li Z, Qiu Y, Lu W, Jiang Y, et al · · 2018 · cited 99× · PMID 29848327 · DOI 10.1186/s12967-018-1514-7
7. TNBC: Potential Targeting of Multiple Receptors for a Therapeutic Breakthrough, Nanomedicine, and Immunotherapy.
   Singh DD, Yadav DK. · · 2021 · cited 76× · PMID 34440080 · DOI 10.3390/biomedicines9080876
8. Immunotherapy in small-cell lung cancer: from molecular promises to clinical challenges.
   Pavan A, Attili I, Pasello G, Guarneri V, et al · · 2019 · cited 74× · PMID 31383005 · DOI 10.1186/s40425-019-0690-1