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Pembrolizumab for Melanoma

Phase 1
Waitlist Available
Led By Brendan Curti, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anticipated lifespan greater than 12 weeks.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days
Awards & highlights

Study Summary

This trial is testing a new drug, GR-MD-02, in combination with the standard dose of pembrolizumab, in patients with advanced melanoma, non-small cell lung cancer, or head and neck squamous cell cancer.

Eligible Conditions
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are expected to live for at least 12 more weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and Severity of Treatment-Related Adverse Events Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Secondary outcome measures
Assess the biological activity of GR-MD-02 in combination with pembrolizumab.
Measure the response rate to combined therapy with GR-MD-02 and pembrolizumab in patients.

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

4Treatment groups
Experimental Treatment
Group I: 8 mg/kg GR-MD-02Experimental Treatment2 Interventions
8 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
Group II: 4 mg/kg GR-MD-02 17 Cycles MaximumExperimental Treatment2 Interventions
4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment up to a maximum of 17 cycles.
Group III: 4 mg/kg GR-MD-02Experimental Treatment2 Interventions
4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
Group IV: 2 mg/kg GR-MD-02Experimental Treatment2 Interventions
2 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GR-MD-02
2013
Completed Phase 2
~270
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
115 Previous Clinical Trials
122,487 Total Patients Enrolled
10 Trials studying Melanoma
268 Patients Enrolled for Melanoma
Galectin Therapeutics Inc.Industry Sponsor
11 Previous Clinical Trials
691 Total Patients Enrolled
1 Trials studying Melanoma
8 Patients Enrolled for Melanoma
Brendan Curti, MDPrincipal InvestigatorProvidence Health & Services
9 Previous Clinical Trials
251 Total Patients Enrolled
3 Trials studying Melanoma
63 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being taken for this research project?

"At this time, the trial is not seeking out patients. Originally posted on May 16th 2016 and most recently updated July 13th 2022, it appears to have paused recruitment for now. If you are considering other options, there are 5030 studies currently recruiting melanoma sufferers as well as 962 trials looking for Pembrolizumab participants."

Answered by AI

What are the most common indications of Pembrolizumab treatment?

"Pembrolizumab is often employed to combat malignant neoplasms, however it can also be beneficial in cases of unresectable melanoma, microsatellite instability high levels and disease progression after chemotherapy."

Answered by AI

Are there any other investigations involving Pembrolizumab that have yielded results?

"Currently, there are 962 ongoing clinical trials exploring the effects of Pembrolizumab with 123 in Phase 3. Numerous locations across 35876 sites have been carrying out these trials; one such region is Houston, Texas."

Answered by AI

What is the upper bound of participants in this experiment?

"Unfortunately, this trial is not currently accepting new participants. Originally posted on May 16th 2016 and last amended July 13th 2022, the study has reached its recruitment target. Patients seeking other medical trials may want to explore the 5030 melanoma studies and 962 Pembrolizumab inquiries which are still open for enrolment."

Answered by AI

Has the U.S Food and Drug Administration sanctioned Pembrolizumab for therapeutic usage?

"The safety of Pembrolizumab is estimated to be a 1 due to the limited data available from Phase 1 trials. This suggests that there is minimal evidence backing its efficacy and security."

Answered by AI
~4 spots leftby Mar 2025