NCT03610061: RaDD

A Trial of Radiotherapy and Durvalumab in DLBCL and FL

Completed Phase 1 Last updated 12 April 2024

What this trial tests

Phase 1 trial testing Durvalumab in Diffuse Large B Cell Lymphoma in 34 participants. Completed in 8 April 2024.

Timeline

1 November 2018

Primary endpoint
5 April 2023

8 April 2024

Quick facts

Lead sponsor	Austin Health
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	1 November 2018
Primary completion	5 April 2023
Estimated completion	8 April 2024
Sites	3 locations across Australia

Drugs / interventions tested

• Durvalumab — full drug profile →
• Radiotherapy — full drug profile →
• Radiotherapy (cohort 6 only)

Conditions studied

• Diffuse Large B Cell Lymphoma — all drugs for Diffuse Large B Cell Lymphoma →
• Follicular Lymphoma — all drugs for Follicular Lymphoma →

Sponsor

Austin Health — full company profile →

Who can join

18 and older, any sex, with Diffuse Large B Cell Lymphoma or Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective for this study is to determine the safety profile of radiotherapy and durvalumab, a PD-L1 inhibitor.

Primary endpoint:

Toxicity, drug pharmacokinetics (PK), maximum tolerated dose (MTD) and recommended phase two dose (RPTD) of simultaneous radiotherapy plus durvalumab in patients with relapsed or refractory DLBCL or FL.

Secondary endpoints:

* ORR
* Progression-free survival
* Overall survival

Exploratory endpoints include description of biological effects of combination radiotherapy plus durvalumab (Imaging results, immune function, PK and PD-see 'research methodologies') and in the PET-Sub-Study, biodistribution of 89Zr Durvalumab and 89Zr-IAB22M2C.

Publications & conference data

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

1. Imaging of T-cells and their responses during anti-cancer immunotherapy.
   Krekorian M, Fruhwirth GO, Srinivas M, Figdor CG, et al · · 2019 · cited 79× · PMID 31656546 · DOI 10.7150/thno.37924
2. Radiolabeled Antibodies for Cancer Imaging and Therapy.
   Parakh S, Lee ST, Gan HK, Scott AM. · · 2022 · cited 78× · PMID 35326605 · DOI 10.3390/cancers14061454
3. Molecular imaging biomarkers for immune checkpoint inhibitor therapy.
   van de Donk PP, Kist de Ruijter L, Lub-de Hooge MN, Brouwers AH, et al · · 2020 · cited 74× · PMID 32042331 · DOI 10.7150/thno.38339
4. Combination of immune checkpoint inhibitors with radiation therapy in cancer: A hammer breaking the wall of resistance.
   Voronova V, Vislobokova A, Mutig K, Samsonov M, et al · · 2022 · cited 35× · PMID 36544712 · DOI 10.3389/fonc.2022.1035884
5. How Non-invasive <i>in vivo</i> Cell Tracking Supports the Development and Translation of Cancer Immunotherapies.
   Iafrate M, Fruhwirth GO. · · 2020 · cited 29× · PMID 32327996 · DOI 10.3389/fphys.2020.00154
6. Imaging cellular immunotherapies and immune cell biomarkers: from preclinical studies to patients.
   Volpe A, Adusumilli PS, Schöder H, Ponomarev V. · · 2022 · cited 19× · PMID 36137649 · DOI 10.1136/jitc-2022-004902
7. Next Generation Imaging Techniques to Define Immune Topographies in Solid Tumors.
   Pietrobon V, Cesano A, Marincola F, Kather JN. · · 2020 · cited 11× · PMID 33584676 · DOI 10.3389/fimmu.2020.604967
8. Novel Tracers and Radionuclides in PET Imaging.
   Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012