LTX-315 in combination with pembrolizumab for Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Cancer+3 More
LTX-315 in combination with pembrolizumab - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a new drug can be injected into a tumor.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Melanoma
  • Advanced Melanoma
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether LTX-315 in combination with pembrolizumab will improve 3 primary outcomes in patients with Cancer. Measurement will happen over the course of Through study completion, an average of 6 months.

Month 6
Clinical benefit rate (CBR)
Objective response rate (ORR)
Overall survival (OS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
LTX-315 in combination with pembrolizumab

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. LTX-315 In Combination With Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

LTX-315 in combination with pembrolizumab
CombinationProduct
LTX-315 will be injected directly into the selected tumor lesion(s) at Days 1, 2, 3, 8, 15, 22, and 29.The number of injections required per lesion depends on lesion size. Pembrolizumab will be dispensed and administered as an IV infusion.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 6 months for reporting.

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have unresectable Stage III A, B, C, or Stage IVm1a metastatic melanoma. show original
For patients who have refused prior standard-of-care treatment as indicated for their specific tumor type, the patient's reason for refusing standard therapy for their disease shall be clearly documented in the study electronic case report form prior to study participation.
All patients must have received anti-PD-1 or anti-PD-L1 in addition to complying with the relevant criteria below (anti-PD-1 or anti-PD-L1 need not be the most recent line of therapy). Melanoma patients with BRAF (v-raf murine sarcoma viral oncogene homolog B1) mutation who are eligible and suitable for BRAF inhibitor therapy should have received specific BRAF inhibitor therapy before enrolling in this study. Patients who have refused BRAF inhibitor therapy are also eligible for the study.
The patients should have had radiologically progressive disease after the most recent line of systemic therapy (no more than 3 prior lines). show original
Anti-PD-1 or anti-PD-L1 does not need to be the most recent line of therapy prior to study entry.
You have cancer that is not amenable to further radiotherapy or surgery for cancer treatment. show original
Have at least 1 superficial, nonvisceral tumor lesion accessible for injection via cutaneous, subcutaneous, or intramuscular route. Note, lymph nodes with metastatic disease may be selected for injection if they are superficial, but not if deep-seated; visceral lesions must not be selected for injection. The lesion must not be located close to airways, defined as close enough to jeopardize the patient's safety, in the opinion of the investigator, in the event of a local reaction to LTX-315 injection (for example, if such a reaction has the potential to interfere with swallowing or result in hemorrhaging into the airways). The size of the lesion(s) selected for injection must be ≥0.5 cm, and preferably ≤3 cm in the longest diameter. For larger lesions, approval from the sponsor and medical monitor is needed prior to enrollment.
The tumor must be measurable with a longest diameter ≥1.0 cm show original
Have a life expectancy ≥3 months.
You have a minimum age of 18 years.\n show original

Patient Q&A Section

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

What are common treatments for cancer?

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Common treatment options for cancer are surgery, chemotherapy, radiation therapy, targeted therapy as well as combinations of these treatment options. There is no cure for cancer so prevention is the best way to control this disease. common treatments for cancer treatment is highly dependent on the type of cancer and how advanced it is.

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What is cancer?

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Cancer is a disease that can be fatal, but it is treatable when it is discovered in an early stage. Cancer cells develop the propensity to grow uncontrollably through a process called metastasis - a key step in cancer recurrence. Survival depends largely on whether the cancer has been diagnosed and on whether or not the cancer has been cured. When a cancer has gone into remission, or is in remission, it will always come back.\n

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What are the signs of cancer?

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There are many signs of cancer. The signs may include swelling, itching, an abnormal lump or mass, change in bowel or bladder habits, and tiredness. An examination by a doctor is the best way to make a diagnosis which can then be confirmed either post-surgery or through diagnostic tests.

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How many people get cancer a year in the United States?

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Over 11 million Americans fall ill with cancer at some time in their life. Most (86.8%) of these people are older and many have a history of chronic illnesses.

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What causes cancer?

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Over the last 15 years, some of the changes to the environment in the environment of the world have allowed the development of a number of cancer causing agents, some of which are a growing problem. The main cancer-causing agents are carcinogens, mutagens (including radiation), and carcinogens in environmental particles such as tobacco smoke and cigarette smoke. Cancer can also result from other environmental agents (including infectious agents), and from stress or injury to the body. The main type of cancer causing agent is tobacco (mainly in the form of smoke) and the main type of cancer causing agents from any type of cancer causing agent is cancer. The most common cancer is lung cancer, followed by stomach cancer and breast cancer.

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Can cancer be cured?

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Caught in the middle between treatment options for many cancers, such as prostate cancer, it is not likely that cancer (especially cancer with no risk of metastases) can be cured and is unlikely to be cured if symptomatic. Treatment of cancer may be as effective as symptomatic treatment although it is far more expensive. Symptoms and the disease can be cured but the disease will be asymptomatic. When no metastases are observable, the disease can be effectively treated with symptomatic treatment.

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What does ltx-315 in combination with pembrolizumab usually treat?

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In selected cases high-grade urothelial cancers and selected cases of SCC can be treated with Ltx-315 and pembrolizumab combined with complete and durable response observed in most cases.

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How does ltx-315 in combination with pembrolizumab work?

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Results from a recent paper underscore the potential use of Ltx-315 in combination with PD1 blockade to enhance CD8 T cell responses and provide rationale for the evaluation of Ltx-315 as an immunotherapeutic option in clinical trials for patients with advanced HNSCC.

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Who should consider clinical trials for cancer?

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The value of CTs as a part of clinical evaluation in the management of cancer is indisputable. Recent findings of clinical trials show that clinicians often fail to identify the patients who are most likely to benefit from treatment with anticancer drugs. As a matter of fact, no single study shows that the combination of a new drug with conventional chemotherapy can improve survival in all patients.

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How serious can cancer be?

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Cancers are rarely lethal even when they are advanced (Stage IV, with or without metastases) but are nonetheless debilitating. This burden deserves the attention of all who care for cancer patients and is an indication why some patients do not adhere to common beliefs that patients can overcome their disease. These ideas would resonate with other patients that are dying, as they might want to think about a more “real” death while considering their own outcomes to be that of a terminally ill patient experiencing what they call “the final hours.” I find this perspective absolutely appropriate to the care of a terminal dying cancer patient because it is important to consider the patient's needs for care even with death approaching.

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Is ltx-315 in combination with pembrolizumab typically used in combination with any other treatments?

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Recent findings demonstrated that the combination of pembrolizumab in combination with an Ltx-315-based regimen is often used in combination with other agents to achieve response or stability in patients with EGFR+ NSCLC or SCLC, and that this does not substantially alter the efficacy of the regimen compared with use without the Ltx-315.

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What is ltx-315 in combination with pembrolizumab?

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The Ltx-315/pembrolizumab combination resulted in clinical activity with limited toxic effect in a heavily pretreated patient population. Ltx-315 alone did not produce any clinical activity. We recommend Ltx-315 in combination with pembrolizumab for patients with platinum- resistant or refractory CTCL.

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