Table 3.

Use of TLR9 agonists as adjuvant in registered clinical trials (*information taken from Clinicaltrials.gov).

Number	*NCT number and tide	Cancer type (number of subjects to enroll)	Intervention(s)	Trial type	Status	Sponsor/collaborators
1	NCT02668770 Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies	Advanced solid cancers including melanoma (60)	• TLR9 agonist - MGN1703 • Ipilimumab (recombinant human   IgGl anti-CTLA-4 monoclonal   antibody)	• Phase II, non-randomized   and open-label.	• Recruiting • Start date: 11 th May   2016 • Completion date:   May 2020	• M.D. Anderson Cancer   Center • Mologen AG
2	NCT02452697 Ph2 NK Cell Enriched DCls vv/vvo RI.R9 Agonist, DUKCPG-001 From Donors Following Allogeneic SCT	Myeloid and lymphoid malignancies (100)	• TI-R9 agonist - DUK-CPG-001 • NK Cell enriched-DLI	• Phase II, randomized and   open-label.	• Recruiting • Start date: 8th June   2016 • Completion date:   July 2023	• David Rizzieri, MD • Agilent Technologies, Inc. • Duke University
3	NCT03326752 Phase lb DV281 With an AntiPD-1 Inhibitor in NSCLC	Advanced NSCLC (80)	• TLR9 agonist - DV281 (synthetic,   aerosolized C-class CpG ODN; RP2D) • Anti-PD-1 Inhibitor	• Phase I, non-randomized   and open-label.	• Recruiting • Start date: 20th Sept   2017 • Completion date:   30th Aug 2020	• Dynavax Technologies   Corporation
4	NCT03618641 CMP-001 in Combo With Nivolumab in Stage 1IIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease	Melanoma and lymph node cancer(20)	• TLR9 agonist - CMP-001 (Virus-like   particle-encapsulated TLR9 agonist) • Nivolumab	• Phase II, sequential   assignment and open-   label.	• Recruiting • Start date: 8th Aug   2018 • Completion date:   15th July 2023	• Diwakar Davar • Checkmate Pharmaceuticals • University of Pittsburgh
5	NCT03507699 Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer	Colorectal carcinoma and liver metastases (19)	• TI-R9 agonist - CMP-001 • Liver radiotherapy • Nivolumab • Ipilimumab	• Phase I, non-randomized   and open-label.	• Active, not yet   recruiting • Star date: 1st Jul   2018 • Completion date:   31st May 2021	• Sheba Medical Center • Checkmate Pharmaceuticals • Bristol-Myers Squibb
6	NCT03445533 A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)	Metastatic melanoma (308)	• TLR9 agonist - IMO-2125 • Ipilimumab	• Phase III, randomized and   open-label.	• Recruiting • Start date: 28th Feb   2018 • Completion date: 1st   Jul 2020	• Idera Pharmaceuticals, Inc. • Bristol-Myers Squibb
7	NCT03410901 TLR9 Agonist SDS-101, Anti-OX40 Antibody BMS 986178, and radiotherapy in Treating Patients With Low Grade B-Cell Non-Hodgkin Lymphomas	B-cell Non-Hodgkin lymphoma (15)	• TLR9 Agonist - SDS-101 • Anti-necrosis factor receptor   superfamily member 4 (0X40)   antibody [BMS 986178) • radiotherapy	• Phase I, single group   assignment and open-   label.	• Recruiting • Start date: 9th April   2018 • Completion date: 9th   Oct 2020	• Ronald Levy • NCI • Stanford University
8	NCT03007732 Pembrolizumab in Combination With Intratumoral SDS- 101 Therapy	Prostate cancer (42)	• TLR9 agonist - SDS-101 • Pembrolizumab • Leuprolide acetate and abiraterone   acetate • Prednisone (synthetic glucocorticoid) • Stereotactic body radiotherapy	• Phase I, randomized and   open-label.	• Recuiting • Start date: 27th April   2017 • Completion date:   April 2022	• Lawrence Fong • University of California, San   Francisco
9	NCT02927964 TLR9 Agonist SDS-101, Ibrutinib, and radiotherapy in Treating Patients With Relapsed or Refractory Grade 1- 3A Follicular Lymphoma	Follicular lymphoma including recurrent and recurrent forms (30)	• TLR9 agonist - SDS-101 • Ibrutinib (small-molecule inhibitor of   Bruton’s tyrosine kinase) • radiotherapy	• Phase I/II, single group   assignment and open-   label.	• Recruiting • Start date: Nov 2016 • nov.16 • Completion date:   Nov 2021	• Robert Lowsky • NCI • Stanford University