NCT00658892

Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Completed Phase 1 Last updated 25 May 2017

What this trial tests

Phase 1 trial testing B7-DC cross-linking antibody rHIgM12B7 in Melanoma (Skin) in 7 participants. Completed in 22 May 2012.

Timeline

8 April 2008

Primary endpoint
15 February 2010

22 May 2012

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	8 April 2008
Primary completion	15 February 2010
Estimated completion	22 May 2012
Sites	1 location across United States

Drugs / interventions tested

• B7-DC cross-linking antibody rHIgM12B7 — full drug profile →
• flow cytometry
• immunologic technique
• laboratory biomarker analysis — full drug profile →

Conditions studied

• Melanoma (Skin) — all drugs for Melanoma (Skin) →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 120, any sex, with Melanoma (Skin). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.

Publications & conference data

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

1. B7 family checkpoint regulators in immune regulation and disease.
   Ceeraz S, Nowak EC, Noelle RJ. · · 2013 · cited 228× · PMID 23954143 · DOI 10.1016/j.it.2013.07.003
2. The Evolving Role of Immune Checkpoint Inhibitors in Cancer Treatment.
   Pennock GK, Chow LQ. · · 2015 · cited 172× · PMID 26069281 · DOI 10.1634/theoncologist.2014-0422
3. Immune checkpoint inhibitor combinations in solid tumors: opportunities and challenges.
   Kyi C, Postow MA. · · 2016 · cited 128× · PMID 27349981 · DOI 10.2217/imt-2016-0002
4. Programmed cell death-ligand 2: A neglected but important target in the immune response to cancer?
   Solinas C, Aiello M, Rozali E, Lambertini M, et al · · 2020 · cited 61× · PMID 32622310 · DOI 10.1016/j.tranon.2020.100811
5. Immune checkpoint receptors in regulating immune reactivity in rheumatic disease.
   Ceeraz S, Nowak EC, Burns CM, Noelle RJ. · · 2014 · cited 58× · PMID 25606596 · DOI 10.1186/s13075-014-0469-1
6. Clinical Implications of Co-Inhibitory Molecule Expression in the Tumor Microenvironment for DC Vaccination: A Game of Stop and Go.
   Vasaturo A, Di Blasio S, Peeters DG, de Koning CC, et al · · 2013 · cited 50× · PMID 24348481 · DOI 10.3389/fimmu.2013.00417
7. Next steps in immuno-oncology: enhancing antitumor effects through appropriate patient selection and rationally designed combination strategies.
   Salama AK, Moschos SJ. · · 2017 · cited 40× · PMID 28177433 · DOI 10.1093/annonc/mdw534