Melanoma Clinical Trials

5 trials identified.

IMCgp100-201 Melanoma
Principal Investigator: Salama, April
Protocol Number: PRO00067271

Age Group: Adult
Scope: National

Phase: I/II (Cancer Control)
Disease Site: Melanoma, skin

Contact: DCI Clinical Research Team, Melanoma and other Skin
Email:

What is the Condition Being Studied?
Stage 3 or Stage 4 Melanoma
What is the Purpose of this Study?
We are doing this study to find out if the study drug IMCgp100 is safe when it is given alone or when IMCgp100 is given with durvalumab and tremelimumab.  We want to learn if the therapies can make melanoma tumors stop growing (or shrink) and if patients with melanoma can live longer and feel better.
Who Can Participate in the Study?
Adults who:
- Have stage 3 or stage 4 melanoma
- Test positive for the protein HLA-A*0201 in the blood
What is Involved?
This study has a pre-screening period where your blood will be tested to see if you have a certain protein.  If you do have this protein, then you may join the study.

If you choose to join this study, you will: 
- Have a screening exam that includes a physical exam, blood tests and CT scans after you finish your pre-screening visit.

- Be assigned to one of the 4 groups to test different therapy combinations:

 Group 1: IMCgp100 plus durvalumab
 Group 2: IMCgp100plus tremelimumab
 Group 3: IMCgp100 plus durvalumab and tremelimumab
 Group 4: IMCgp100 alone

- Get the therapy every week for the first year on this study and will need to stay overnight in the hospital for the first three weeks
- Get therapy every 4 weeks for the second year on the study
-- While your are getting the therapy, you will have CT scans every three months and several blood tests.  
- Be followed for 2 years after you stop therapy to watch your condition
Participating Institutions:
  • Duke University Health System : Melanoma and other Skin DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Delcath FOCUS Study for Metastatic Uveal Melanoma
Principal Investigator: Beasley, Georgia
Protocol Number: PRO00069107

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Melanoma, skin

Contact: DCI Clinical Research Team, Melanoma and other Skin
Email:

What is the Condition Being Studied?
Uveal Melanoma
What is the Purpose of this Study?
We are doing this study is to find out if the Melphalan /HDS therapy is effective for people with uveal melanoma that has spread to the liver and to look at side effects of the therapy. We want to find out if the therapy can reduce the size of liver tumors.
Who Can Participate in the Study?
Adults with uveal melanoma (started in the eye) that spread to the liver. 
What is Involved?
If you join the study, you will:
- Have a physical exam and other tests
- Imaging scans (CT scans and MRI scans)
- Receive the Melphalan/HDS therapy up to 6 times, once every 6-8 weeks with blood work every week
- Have liver scans every 10-14 weeks.
Participating Institutions:
  • Duke University Health System : Melanoma and other Skin DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Immunocore Uveal-202: Uveal Melanoma
Principal Investigator: Salama, April
Protocol Number: PRO00082289

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Eye and Orbit

Contact: DCI Clinical Research Team, Melanoma and other Skin
Email:

What is the Condition Being Studied?
Advanced uveal melanoma
What is the Purpose of this Study?
This research study is testing a drug called IMCgp100 and comparing it to standard therapies in patients with uveal melanoma (melanoma starts in the eye) that has spread

We want to compare IMCgp100 safety with the other therapies. We also want to find out if IMCgp100 can make patients with uveal melanoma live longer and feel better, and if IMCgp100 can make uveal melanoma tumors stop growing (or shrink).
Who Can Participate in the Study?
Adults with advanced uveal melanoma (melanoma that starts in the eye) that has spread to other parts of the body.  Must have the  HLA-A*0201 protein in the blood.
What is Involved?
This study has a pre-screening period where your blood will be tested to see if you have a certain protein.  If you do, then you can join the study.

After pre-screening, you will have a screening exam that includes a physical exam, blood tests and CT scans.

You will be randomized (put into one of two groups by chance like a flip of a coin) and get either:

 Group 1: IMCgp100
 Group 2: Standard therapy (ipilimumab every 3 weeks for 4 cycles, pembrolizumab every 3 weeks or dacarbazine every 3 weeks)

If you are assigned to group 1: 
-- You will receive IMCgp100 every week up to 5 years or until your cancer grows or you have severe side effects. 
--You will need to stay overnight in the hospital for the first three weeks.  
-- You will have CT scans every three months and several blood tests while you are getting the therapy.  
-- Your condition will be followed for 2 years after you stop therapy.
Participating Institutions:
  • Duke University Health System : Melanoma and other Skin DCI Clinical Research Team
View this trial at ClinicalTrials.gov

PVSRIPO in Melanoma
Principal Investigator: Beasley, Georgia
Protocol Number: PRO00090774

Age Group: Adult
Scope:

Phase: I
Disease Site: Other

Contact: DCI Clinical Research Team, Melanoma and other Skin
Email:

What is the Condition Being Studied?
Advanced melanoma
What is the Purpose of this Study?
We are doing this study to find out if PVSRIPO is safe and how it affects the injected tumor or other tumors. 
Who Can Participate in the Study?
Adults with stage 3 or stage 4 melanoma who:
- Have been immunized against Polio virus
- Have failed other melanoma therapies
What is Involved?
If you join the study, you will:
- Get the Polio vaccine, PVSRIPO
-- Get 1, 2 or 3 injections depending on when you start in the study
- Have a physical exam and other tests
- Imaging scans (CT scans)
- Biopsy of the tumor on your skin (or just below the skin)
- Be on the study for 12 weeks to 18 weeks, followed by a period of follow-up observation for up to 2 years  
Participating Institutions:
  • Duke Cancer Center Cary : Melanoma and other Skin DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Melanoma and other Skin DCI Clinical Research Team
  • Duke Primary Care : Melanoma and other Skin DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Melanoma and other Skin DCI Clinical Research Team
  • Duke Raleigh Hospital : Melanoma and other Skin DCI Clinical Research Team
  • Duke Regional Hospital : Melanoma and other Skin DCI Clinical Research Team
  • Duke University Health System : Melanoma and other Skin DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Melanoma and other Skin DCI Clinical Research Team
  • Johnston Health (Smithfield) : Melanoma and other Skin DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Melanoma and other Skin DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Melanoma and other Skin DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Melanoma and other Skin DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 9466 Dabrafenib, Trametinib, and Navitoclax in Melanoma & Solid Tumors
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00094262

Age Group: Adult
Scope:

Phase: I/II
Disease Site: Other

Contact: DCI Clinical Research Team, Melanoma and other Skin
Email:

What is the Condition Being Studied?
Melanoma with a mutation, a change in a cancer gene called BRAF that helps cancer grow
What is the Purpose of this Study?
We are doing this study to test the safety and side effects of the study drug navitoclax in combination with dabrafenib and trametinib at different doses.  
Who Can Participate in the Study?
Adults with BRAF-mutant (V600E/K) melanoma that is metastatic (has spread) or is unresectable (cannot be removed using surgery) and for which standard curative measures do not exist or are no longer effective.
What is Involved?
This study is divided into two parts. 

In the first part of this study, you will receive navitoclax for one week by itself before dabrafenib and trametinib are started.  

The second part of this study has two study groups. 
If you are enrolled in the second part of this study, a computer will randomly (like flipping a coin) put you in a study group. This is done because no one knows if one study group is better, the same, or worse than the other group. Once you are put in one group, you cannot switch to the other group. 

Group 1 will get the usual drug combination used for this type of cancer dabrafenib plus trametinib plus a study drug called navitoclax. 

Group 2 will get only the usual drug combination used for this type of cancer consisting of dabrafenib plus trametinib. 
Participating Institutions:
  • Duke Cancer Center Cary : Melanoma and other Skin DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Melanoma and other Skin DCI Clinical Research Team
  • Duke Primary Care : Melanoma and other Skin DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Melanoma and other Skin DCI Clinical Research Team
  • Duke Raleigh Hospital : Melanoma and other Skin DCI Clinical Research Team
  • Duke Regional Hospital : Melanoma and other Skin DCI Clinical Research Team
  • Duke University Health System : Melanoma and other Skin DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Melanoma and other Skin DCI Clinical Research Team
  • Johnston Health (Smithfield) : Melanoma and other Skin DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Melanoma and other Skin DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Melanoma and other Skin DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Melanoma and other Skin DCI Clinical Research Team
View this trial at ClinicalTrials.gov