Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) for Head and Neck Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC Hillman Cancer Center, Pittsburgh, PAHead and Neck Squamous Cell Carcinoma+4 MorePhase II ARRY-614 + nivolumab+ipilimumab (melanoma) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, ARRY-614, to see if it is safe and effective when used with either nivolumab or ipilimumab to treat advanced solid tumors.

Eligible Conditions
  • Solid Tumors
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Non-Small Cell Lung Cancer
  • Kidney Cancer
  • Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 48 months

Month 3
Tumor Inflammation Signature (TIS) score
Month 3
Pharmacodynamic profile of ARRY-614
Month 3
Pharmacokinetic profile of ARRY-614
Day 28
Participants Experiencing a Dose Limiting Toxicity (DLT)
Up to 48 months
Adverse Events related to Study Treatment
Duration of Response
Objective Response
Overall Survival (OS)
Progression Free Survival (PRS)
Response per Immune-related response criteria (irRECIST)

Trial Safety

Trial Design

5 Treatment Groups

Phase Ib ARRY-614 + nivolumab + ipilimumab
1 of 5
Phase Ib ARRY-614 + nivolumab
1 of 5
Phase II ARRY-614 + nivolumab + ipilimumab (RCC)
1 of 5
Phase II ARRY-614 + nivolumab + ipilimumab (melanoma)
1 of 5
Phase II ARRY-614 + nivolumab
1 of 5

Experimental Treatment

144 Total Participants · 5 Treatment Groups

Primary Treatment: Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) · No Placebo Group · Phase 1 & 2

Phase Ib ARRY-614 + nivolumab + ipilimumab
Drug
Experimental Group · 1 Intervention: Phase Ib ARRY-614 + nivolumab+ipilimumab · Intervention Types: Drug
Phase Ib ARRY-614 + nivolumab
Drug
Experimental Group · 1 Intervention: Phase Ib ARRY-614 + nivolumab · Intervention Types: Drug
Phase II ARRY-614 + nivolumab + ipilimumab (RCC)
Drug
Experimental Group · 1 Intervention: Phase II ARRY-614 + nivolumab+ipilimumab (RCC) · Intervention Types: Drug
Phase II ARRY-614 + nivolumab + ipilimumab (melanoma)
Drug
Experimental Group · 1 Intervention: Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) · Intervention Types: Drug
Phase II ARRY-614 + nivolumab
Drug
Experimental Group · 1 Intervention: Phase II ARRY-614 + nivolumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 months

Who is running the clinical trial?

Jason J. Luke, MDLead Sponsor
4 Previous Clinical Trials
747 Total Patients Enrolled
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,471 Total Patients Enrolled
Jason J Luke, MD, PhDPrincipal InvestigatorUPMC Hillman Cancer Center
1 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor expects you to live for at least 3 more months.
If you have melanoma and have not responded well to anti-PD1 treatment, you may qualify for the ARRY-614 plus nivolumab or ARRY-614 plus ipilimumab cohort. If you have RCC and have not responded well to anti-PD1 treatment, you may qualify for the ARRY-614 plus nivolumab cohort. But, if you have melanoma and are going to enter the ARRY-614 plus ipilimumab cohort, you cannot have received ipilimumab therapy before.

Frequently Asked Questions

Are there any prior examinations of the effects of a combination therapy of Phase II ARRY-614, nivolumab and ipilimumab for melanoma?

"Presently, there are 765 clinical trials for Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) in progress with 86 of these at the final stage. Although a few of them take place in Pittsburgh, PA, 42707 other sites host studies about this medication." - Anonymous Online Contributor

Unverified Answer

Are volunteers being enrolled for this clinical research currently?

"As per the clinicaltrials.gov registry, this medical trial is currently in need of participants. The initial posting was made on June 11th 2020 and editted as recently as January 9th 2022." - Anonymous Online Contributor

Unverified Answer

What results are expected to arise from the investigation of this clinical trial?

"This 28-day clinical trial will be assessing the Objective Response rate of patients. Secondary objectives include measuring Overall Survival, Duration of Response and Progression Free Survival via RECIST v1.1 guidelines." - Anonymous Online Contributor

Unverified Answer

What is the current capacity of this research study?

"Affirmative. Clinicaltrials.gov reveals that this clinical examination, which was first published on June 11th 2020, is actively enrolling volunteers. Approximately 144 participants must be enrolled from just one medical site." - Anonymous Online Contributor

Unverified Answer

What primary purpose does the combination of ARRY-614, nivolumab and ipilimumab (melanoma) serve?

"Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) has been successfully used to treat various conditions, including malignant neoplasms, unresectable melanoma and squamous cell carcinoma. It is especially effective for anti-angiogenic therapy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.