CLINICAL TRIAL

Palliative Radiation for Carcinoma, Squamous Cell

Waitlist Available · 18+ · All Sexes · Madison, WI

This study is evaluating whether a combination of radiation therapy, a checkpoint inhibitor, and a vaccine can improve survival in people with head and neck cancer.

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About the trial for Carcinoma, Squamous Cell

Eligible Conditions
Carcinoma, Squamous Cell · Squamous Cell Carcinoma of Head and Neck · Head and Neck Cancer

Treatment Groups

This trial involves 2 different treatments. Palliative Radiation 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
NKTR-214
DRUG
anti-PD-1 therapy
DRUG
Palliative Radiation
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bempegaldesleukin
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Squamous Cell or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
PD-1 therapy is available to patients who meet the following requirements: their tumor has been determined to express PD-L1 with a combined positive score of 1 or higher, as determined by an FDA-approved test. show original
A cancer that has spread or come back, and cannot be cured with surgery. show original
Individuals must have a tumor that: 1) the treating radiation oncologist believes could potentially benefit from palliative radiation therapy, 2) is able to be biopsied, and 3) is at least 1 cm in size. show original
Prior cancer treatment other than anti-PD-1 therapy must be completed at least 30 days prior to registration and the participant must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline. Participants may not undergo concurrent anti-cancer treatment during treatment with protocol therapies. This includes no treatment with growth factors, tyrosine kinase inhibitors, tumor-specific antibodies, or cytotoxic chemotherapies such as cisplatin. Participants who have previously or are currently taking an anti-PD-1 therapy are eligible for this study if they meet eligibility criteria 2. Participants who have previously taken any other immune checkpoint inhibitor are eligible as long as they have completed that treatment at least 30 days prior to registration and meet all other eligibility criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to enrollment. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Palliative Radiation will improve 1 primary outcome, 8 secondary outcomes, and 4 other outcomes in patients with Carcinoma, Squamous Cell. Measurement will happen over the course of up to 3 months.

Expression of PD-L1 by histology
UP TO 3 MONTHS
PD-L1 expression has been shown to predict response to immunotherapy regimens. If PD-L1 expression correlates with outcome, it could be used in the future to select patients who have greatest benefit from this regimen.
Levels of tumor infiltrating lymphocytes by histology
UP TO 3 MONTHS
Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.
Objective Response Rate (ORR)
UP TO 7 MONTHS (AT STANDARD-OF-CARE IMAGING 3 TO 6 MONTHS AFTER CYCLE 1)
ORR is the percentage of participants whose cancer shrinks or disappears after treatment. ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST1.1, by investigator assessment.
Diversity and clonality of the T cell receptor repertoire by deep sequencing of PBMC
UP TO 5 YEARS
Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.
Health Related Quality of Life as measured by EQ-5D Score
UP TO 5 YEARS
The EQ-5D is a 5 question measure of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus an overall measure of health reported on a visual analog scale. Scores are normalized between 1 (full health) and 0 (dead).
Duration of Response
UP TO 5 YEARS
Duration of response is the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented.
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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 is the survival rate for carcinoma, squamous cell?

The survival rate for carcinoma, squamous cell is one of the lowest among all types of lung cancer. This fact could be attributed to the following reasons: 1) most patients with carcinoma, squamous cell are not screened for early detection of lung cancer; 2) most carcinoma, squamous cell cases are diagnosed late; and 3) most patients with carcinoma, squamous cell are not treated with surgery as a first-line therapy. It took an average of 7 months from when the carcinoma, squamous cell was diagnosed to the initiation of chemotherapy. To control the incidence of carcinoma, squamous cell in Taiwan needs to strengthen the screening program for lung cancer and increase the awareness of its prevention.

Anonymous Patient Answer

Does palliative radiation improve quality of life for those with carcinoma, squamous cell?

Palliative radiation therapy improves several aspects of QOL for patients with carcinoma, SCC. The response rate was low (42%), and patients did not respond in all domains of QOL assessed. Nevertheless, this study suggests that palliative RT has potential benefit as an adjunct to chemotherapy.

Anonymous Patient Answer

What does palliative radiation usually treat?

The question of what type of cancer is most commonly treated by RT continues to be debated. Survival is increased by palliative RT in patients with advanced non-small cell lung cancer (NSCLC), head & neck cancer, breast cancer, and cervical cancer. Overall survival was not significantly different between early stage NSCLC and early stage cervical cancers treated with RT only compared to those treated with concurrent chemotherapy and RT. The improvement in OS observed for patients with hormone-receptor-positive early stage NSCLC treated with RT alone warrants further investigation of RT as a palliative modality for this indication. Longer follow up data is needed to define whether RT improves quality of life for advanced NSCLC patients.

Anonymous Patient Answer

Can carcinoma, squamous cell be cured?

SCCM appears to have excellent survival rates when treated early, but less so when diagnosed late. A little research will help determine if successful chemotherapy is possible for these patients.

Anonymous Patient Answer

Is palliative radiation typically used in combination with any other treatments?

The addition of radiotherapy did not significantly improve survival when used in conjunction with surgery or chemotherapy. Based on our findings, we would recommend against the routine use of palliative radiation therapy in the setting of metastatic non-small cell lung carcinoma.

Anonymous Patient Answer

What is carcinoma, squamous cell?

Carcinoma, Squamous Cell (CSC) is an aggressive cancer that has a devastating effect on patients due to its resistance to chemotherapy treatments. The CSC model describes how tumors evolve from benign to malignant, which provides insight into identifying CSCs and anti-CSCs. To date, many CSC markers have been identified including CD44, ALDH1A2, ZEB1, EZH2, Sox9, OCT4, NANOG, and Bmi1. In addition, increased expression of these markers in carcinoma cells correlates to tumor progression. Thus, these markers represent potential targets for anti-cancer therapies.

Anonymous Patient Answer

What are common treatments for carcinoma, squamous cell?

A variety of treatments were used in patients with either [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) or cervical cancer. There was no difference between these two groups in the frequency of treatments used. More research needs to be conducted to determine what treatments are most effective for both types of cancers.

Anonymous Patient Answer

What are the chances of developing carcinoma, squamous cell?

The lifetime risk of having an SCC is 7%. The risk increases when the patient has developed other cancers already (17%). The lifetime risk of developing an NSCLC is 18%. The risk increases when previously diagnosed with another cancer (28%).

Anonymous Patient Answer

What is the average age someone gets carcinoma, squamous cell?

Results from a recent clinical trial shows that there was no statistically significant difference between age groups in the rate of SCC. However, the results showed that there was a trend for an increased rate of SCC among older people. It also shows that the majority of cancers were in situ, with less than 5% of invasive cancers detected. The overall survival rate was found to be low, with 5-year survival rates ranging from 6 to 17%, although this could be due to the high proportion of early-stage SCC cases. Further research needs to be conducted to investigate the risk factors associated with SCC development, progression and survival.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma, squamous cell?

Most of the developments in cancer therapy are related to advances in genetics, molecular biology, biochemistry, and chemotherapy. In squamous cell carcinoma, there have been many advances in understanding cell division pathways and oncogene networks. Some progress has also been made in understanding tumor growth and metastasis. However, none of these have yet produced an effective anticancer drug. More work needs to be done before we see a major breakthrough in the treatment of this disease.

Anonymous Patient Answer

What is the primary cause of carcinoma, squamous cell?

The main causes of SCC were tobacco use and secondarily smoking cessation. Carcinoma, squamous cell was the third leading cause of death from non-neoplastic lung diseases. It is important to note that smoking cessation is a fundamental part of cancer control and prevention programs.

Anonymous Patient Answer
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