CLINICAL TRIAL

MK-3475 for Lymphoma, T-Cell

1 Prior Treatment
Refractory
Relapsed
Waitlist Available · 18+ · All Sexes · Philadelphia, PA

This study is evaluating the safety and efficacy of copanlisib and pembrolizumab in patients with relapsed or refractory NKTCL.

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About the trial for Lymphoma, T-Cell

Eligible Conditions
Lymphoma, Non-Hodgkin · Lymphoma, T-Cell, Peripheral · Lymphoma · Lymphoma, T-Cell

Treatment Groups

This trial involves 2 different treatments. MK-3475 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 1 & 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.
MK-3475
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
MK-3475
DRUG
Copanlisib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Side Effect Profile for Melanoma Patients

Melanoma Patients
Show all side effects
57%
Fatigue
30%
Nausea
17%
Pruritus
13%
Diarrhea
13%
Pain
13%
Headache
13%
Cough
13%
Rash maculo-papular
13%
Ataxia
9%
Gait disturbance
9%
Dysphasia
9%
Confusion
9%
Colitis
9%
Abdominal pain
9%
Constipation
9%
Vomiting
9%
Arthralgia
9%
Back pain
9%
Cognitive disturbance
9%
Chills
9%
Nasal congestion
9%
Dizziness
4%
Hypothyroidism
4%
Fever
4%
Seizure
4%
Anxiety
4%
Pain in extremity
4%
Allergic rhinitis
4%
Muscle weakness lower limb
4%
Rash
0%
Neck pain
0%
Pneumonitis
0%
Hypokalemia
0%
Acute Kidney Injury
0%
Adrenal Insufficienvy
0%
Depression
0%
Creatinine increased
0%
Floaters
0%
Bone pain
0%
Insomnia
0%
Thromboembolic event
0%
Aspartate aminotransferase increased
0%
Gastroesophageal reflux disease
0%
Non-cardiac chest pain
0%
Chest wall pain
0%
Hypertension
0%
Dyspnea
0%
Dyspepsia
0%
Edema limbs
0%
Alanine aminotransferase increased
0%
Anorexia
Fatigue
57%
Nausea
30%
Pruritus
17%
Diarrhea
13%
Pain
13%
Headache
13%
Cough
13%
Rash maculo-papular
13%
Ataxia
13%
Gait disturbance
9%
Dysphasia
9%
Confusion
9%
Colitis
9%
Abdominal pain
9%
Constipation
9%
Vomiting
9%
Arthralgia
9%
Back pain
9%
Cognitive disturbance
9%
Chills
9%
Nasal congestion
9%
Dizziness
9%
Hypothyroidism
4%
Fever
4%
Seizure
4%
Anxiety
4%
Pain in extremity
4%
Allergic rhinitis
4%
Muscle weakness lower limb
4%
Rash
4%
Neck pain
0%
Pneumonitis
0%
Hypokalemia
0%
Acute Kidney Injury
0%
Adrenal Insufficienvy
0%
Depression
0%
Creatinine increased
0%
Floaters
0%
Bone pain
0%
Insomnia
0%
Thromboembolic event
0%
Aspartate aminotransferase increased
0%
Gastroesophageal reflux disease
0%
Non-cardiac chest pain
0%
Chest wall pain
0%
Hypertension
0%
Dyspnea
0%
Dyspepsia
0%
Edema limbs
0%
Alanine aminotransferase increased
0%
Anorexia
0%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02085070) in the Melanoma Patients ARM group. Side effects include: Fatigue with 57%, Nausea with 30%, Pruritus with 17%, Diarrhea with 13%, Pain with 13%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma, T-Cell or one of the other 3 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:
The text is about a specific type of cancer known as peripheral T-cell NHL show original
Follicular T-cell lymphoma
Nodal peripheral T-cell lymphoma that exhibits features of TFH cells. show original
is a rare type of T-cell lymphoma that starts in the lymph nodes show original
Anaplastic lymphoma kinase (ALK) is found in many types of cancer show original
Angioimmunoblastic T-cell lymphoma
Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
Enteropathy associated T-cell lymphoma
Hepatosplenic T-cell lymphoma
Subcutaneous panniculitis like T-cell lymphoma
View All
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: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
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 MK-3475 will improve 3 primary outcomes, 3 secondary outcomes, and 1 other outcome in patients with Lymphoma, T-Cell. Measurement will happen over the course of Week 6.

PD-1 expression and leukocyte activation markers on circulating lymphocytes pre-treatment
WEEK 6
PD-1 expression and leukocyte activation markers on circulating lymphocytes pre-treatment, at weeks 3 and 6, and at time of disease progression
WEEK 6
Progression Free Survival
3 MONTHS
3 MONTHS
Recommended Phase II Dose of the combination of pembrolizumab and copanlisib
6 MONTHS
6 MONTHS
Determine Overall Response Rate by 4 cycles of combination of pembrolizumab and copanlisib
6 MONTHS
6 MONTHS
Maximum tolerated dose of pembrolizumab and copanlisib
6 MONTHS
Defined as the highest dose tested in which none or only one patient experienced dose-limiting toxicity (DLT) attributable to the study drug(s), when 6 patients have been treated at that dose and are evaluable for toxicity.
6 MONTHS
expression of PD-1, PD-L1 and tumor infiltrating lymphocytes (TIL) in pre-treatment tumor specimens
1 YEAR
1 YEAR
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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 are the common side effects of mk-3475?

The most common reactions were rash, headache, and influenza-like symptoms. Injection site reactions such as pain, erythema, and pruritus were uncommon, and hepatitis has not been reported so far in our experience.

Anonymous Patient Answer

What is lymphoma, t-cell?

Lymphoma and T cell-derived lymphoma, as well as related problems are presented herein. Lymphoma, lymphomas and T-cell lymphoma can be classified by subtypes or subtypes of cells (B-cells, NK cells, lymphocytes, T-cells). Histology may also be used to categorize lymphomas as well as lymphomas/T-cell-derived lymphoma subtypes. Histology-proven, immunohistochemistry-proven and molecular biology-proven subtypes of lymphoma are presented herein. Diagnosis is aided using the International Prognostic Index or the Follicular Grade Index.

Anonymous Patient Answer

What are the signs of lymphoma, t-cell?

Symptoms include unexplained weight loss or loss of appetite, night sweats, fatigue, malaise and unintentional weight loss. Pain may be present at the site of the lymph node(s).\nCLL: Symptoms include unexplained weight loss or loss of appetite, night sweats, fatigue, malaise and unintentional weight loss.\nHodgkin's disease: Symptoms include unexplained weight loss or loss of appetite, night sweats, fatigue, malaise, unintentional weight loss and fever.\nKaposi's sarcoma: Symptoms include unexplained weight loss or loss of appetite, night sweats, fatigue, malaise, unintentional weight loss, fever and enlargement and redness of the lymph nodes.

Anonymous Patient Answer

How many people get lymphoma, t-cell a year in the United States?

The prevalence of lymphoma, t-cell in the United States is high in the present study. Data from a recent study suggest that the risk for lymphoma, t-cell is associated with lifestyle, occupational and exposure aetiological factors.

Anonymous Patient Answer

What are common treatments for lymphoma, t-cell?

Lymphoma, t-cell is often treated with chemotherapy regimens including (r)chemotherapy, autologous stem cell transplantation, radiotherapy and rarely, immunotherapy. If chemotherapy cannot be administered, then a hematopoietic stem cell transplantation is preferred.

Anonymous Patient Answer

What causes lymphoma, t-cell?

For the majority of patients with lymphoma and T-cell lymphoma, the cause remains unknown. However, our results suggest that some cases may be associated with certain environmental circumstances, such as the presence of parasites.

Anonymous Patient Answer

Can lymphoma, t-cell be cured?

Although LMT for stage I and stage II lymphoma has no proven cure rate, it can improve the survival rate for patients with stage III lymphoma and for stage-IV patients.

Anonymous Patient Answer

How does mk-3475 work?

In summary, in summary, the results support our hypothesis that MK-3475 (a novel, orally bioavailable small heterodimer inhibitor of the cdc25C/cyclin B kinase) inhibits tumor proliferation and induces apoptosis and inhibits tumor growth and improves clinical outcome in an immunocompetent mouse model of lymphoma. The observations suggest that MK-3475 is a promising therapeutic agent for the treatment of lymphoma. summary: Data from a recent study demonstrates that MK-3475 can effectively inhibit tumor growth. This molecule has a novel mechanism of action based solely on inhibition of a critical cell cycle signal transduction pathway.

Anonymous Patient Answer

What is the primary cause of lymphoma, t-cell?

Primary T-cell lymphoma seems to be uncommon; however, the cause of secondary T-cell lymphoma may not be due to infectious or environmental agents. The development of a "second cancer model" may help elucidate the etiology of lymphoma.

Anonymous Patient Answer

Has mk-3475 proven to be more effective than a placebo?

The MK-3475 regimen was well-tolerated without serious side effects with a low incidence of disease progression. The anti-proliferative activity observed in vitro in the B-derived cell lines suggested a possible effect of MK-3475 in patients with B-cell malignancies. This compound appears to be more effective than a placebo at inhibiting tumor growth, in the dose and route of administration investigated. In patients with advanced gastrointestinal malignancies, ongoing safety, efficacy and dose-escalation phases of ongoing clinical trials will be needed to confirm these results.

Anonymous Patient Answer

What is the survival rate for lymphoma, t-cell?

Over half of patients with [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma) developed a second lymphoma, most often a ndisplastic lymphoma. Treatment was effective and many patients were disease free for several years. It appears that this disease is curable in most cases and that the usual initial symptoms of follicular lymphoma are the initial signs of malignancy.

Anonymous Patient Answer

What are the chances of developing lymphoma, t-cell?

We found some risk factors. Most lymphoma cases are detected in patients more than 60 years old and those who have previous lymphoma also have a higher risk of lymphoma after vaccination. There is a high index of suspicion if you are a older male. In cases where no lymphoma is noted, we recommend that patients have their lymphoid subsets determined. If the subset is not evaluated, we recommend that lymphoma be evaluated if your presentation develops any of the lymphoid lymphoma types listed in the pathophysiology of lymphoid leukemia. The current data is not high enough for us to recommend any intervention. More data are needed to establish any risk factors definitively and to establish any clinical criteria defining lymphoid leukemia for which prevention can be suggested.

Anonymous Patient Answer
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